下腔静脉滤器的应用与研究进展
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甘肃省兰州市科技发展指导性计划基金资助项目(2019-ZD-49)。


Application and research progress of inferior vena cava filters
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    摘要:

    深静脉血栓形成(DVT)是血液在深静脉内异常凝结导致的静脉回流障碍性疾病,常发生于下肢。栓子脱落可引起肺动脉栓塞(PE),DVT与PE统称为静脉血栓栓塞症(VTE),是同种疾病在不同阶段的表现形式。DVT的高发病率及并发PE导致的猝死风险已受到临床医生的密切关注,当VTE患者出现抗凝禁忌或抗凝治疗失败时,可置入下腔静脉滤器(IVCF),通过其网状过滤结构捕获血凝块从而预防致死性PE发生。IVCF现已在全球广泛被应用,根据使用情况,可分为永久型、临时型及可选择回收型。永久型IVCF置入人体后除非手术切开腔静脉否则无法取出,远期滤器断裂、移位、栓塞、症状性下腔静脉穿孔等出现率较高,现已被临床淘汰;临时型IVCF通过与外部的导管和固定设备相接,便于回收但易于感染,临床应用极少;可回收型IVCF具有用于回收的钩状结构,当患者VTE风险期过后,可通过介入手术取出,是目前临床应用的主要类型,但由于部分患者VTE治疗时间超过了滤器留置时间窗,从而引起一系列并发症以及患者随访丢失等原因,导致实际回收率较低,相关争议日益增多。同时新型IVCF的研发正在紧密开展,药物洗脱IVCF使用抗平滑肌增生、抗炎等药物涂覆,可阻止血管内膜的过度增生,延长IVCF的留置时间以便于回收;可转换IVCF允许滤器结构在体内发生转换,由过滤网变形为开放式支架,以期降低远期并发症,但转换后的金属支架无法取出,对腔静脉的远期影响仍需要长期的随访观察;生物可降解IVCF可完全被机体吸收,避免了二次手术,是目前国内外学者研究的热点,但如何设计材料,保证滤器所拦截的血栓吸收之前IVCF保持应有的强度,进而防止血凝块或降解片段再次栓塞的问题目前没有明确的研究数据证实,拥有可控降解特点的新型IVCF是一个明确的研发目标。另一方面,部分学者通过计算机仿真模拟分析不同结构的过滤单元以及不同支撑杆数目对滤器性能的影响,为结构最优化、血流动力学影响最小化的新型IVCF研究提供了更科学的参考与理论依据。综上所述,在倡导推广应用更细致的患者管理和临床随访来提高IVCF取出率的基础上,进一步研发出一款理想的IVCF迫在眉睫,意义重大。新型IVCF应具备以下功能:可有效拦截血凝块,以防止新发或复发PE;在VTE高风险期结束后可远程控制转换或整体同步降解;滤器固定良好,保持良好的径向支撑性能同时不损伤腔静脉壁;具有良好生物相容性;对血流动力学影响较小;可在影像学检查中清晰显影便于随访。相信随着材料学、组织工程领域的深入研究与发展,可早日研制出临床疗效优异、并发症极少的新型IVCF。

    Abstract:

    Deep venous thrombosis (DVT) is a venous reflux disorder caused by abnormal blood coagulation in the deep veins, which often occurs in the legs. Thrombus shedding can cause pulmonary embolism (PE). DVT and PE are collectively referred to as venous thromboembolism (VTE), and it is the manifestation of the same disease in different stages. The High incidence of DVT and the risk of sudden death caused by PE have been widely concerned by clinicians. When anticoagulation is contraindicated or anticoagulation treatment fails in VTE patients, an inferior vena cava filter (IVCF) can be inserted to capture blood clots through its mesh filter structure to prevent fatal PE. IVCF has been widely used in the world. According to the usage, it can be divided into permanent type, temporary type and retrievable type. Permanent IVCF cannot be removed unless the vena cava is surgically incised after implantation, The long-term occurrence rate of filter fracture, displacement, embolism and symptomatic perforation is high, which has been eliminated in clinical practice. Temporary IVCF is easy to be recovered by connecting with external catheter and fixed equipment, but it is easy to be infected, so it is rarely used in clinical practice. The retrievable IVCF has a hook-like structure for retrieving. When the patient's VTE risk period has passed, it can be removed by interventional surgery, which is the main type of clinical application. However, due to a series of complications caused by the treatment time of some patients exceeding the filter indwelling time window and the loss of follow-up, the actual recovery rate is low, and the related disputes are increasing. At the same time, the research and development of new IVCF is being carried out closely. Drug-eluting IVCF is coated with inhibition of smooth muscle proliferation and anti-inflammatory drugs, which can prevent the excessive proliferation of vascular intima, prolong the indwelling time of IVCF and facilitate the retrieval; In order to reduce the long-term complications, convertible IVCF allows the filter structure to be transformed in vivo from filter screen to open stent, but the converted metal stent can’t be removed, and the long-term effect on vena cava still needs long-term follow-up observation; Biodegradable IVCF can be completely absorbed by the body and avoid secondary surgery, which is a hot research topic of scholars at home and abroad. However, there is no clear research data to confirm how to design materials to ensure that IVCF maintains its strength before the thrombus intercepted by the filter is absorbed, so as to prevent the hemostatic clot or degraded fragment from thromboembolism again. The new type of IVCF with controllable degradation characteristics is a clear research and development goal. On the other hand, some scholars have used computer simulation to analyze the influence of different structures of filter units and the number of support rods on the performance of the filter, which provided a more scientific reference and theoretical basis for the study of new type of IVCF with optimal structure and minimal hemodynamic impact. In summary, on the basis of advocating the application of more meticulous patient management and clinical follow-up to improve the IVCF removal rate, it is imminent and significant to further develop an ideal IVCF. The new type of IVCF should have the following functions: it can effectively intercept blood clots to prevent new or recurring PE; after the high-risk period of VTE, it can be remotely controlled for conversion or overall simultaneous degradation; the filter is well fixed, maintaining good radial support performance at the same time does not damage the vena cava wall; has good biocompatibility; has little impact on hemodynamics; can be clearly visualized in imaging examinations for follow-up. It is believed that with the in-depth research and development in the fields of materials science and tissue engineering, a new type of IVCF with excellent clinical efficacy and few complications can be developed as soon as possible.

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屈睿升,周晏仪,张耀明,周栋.下腔静脉滤器的应用与研究进展[J].中国普通外科杂志,2021,30(6):715-722.
DOI:10.7659/j. issn.1005-6947.2021.06.012

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  • 收稿日期:2021-01-19
  • 最后修改日期:2021-06-25
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  • 在线发布日期: 2021-09-03