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下腔静脉滤器的应用与研究进展

屈睿升1,周晏仪1,张耀明2,周栋1

(1.兰州大学第二医院 血管外科,甘肃 兰州 730030;2.中国科学院兰州化学物理研究所,甘肃 兰州 730030)

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。

关键词 静脉血栓栓塞;腔静脉滤器;综述

深静脉血栓形成(deep venous thrombosis,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(pulmonary embolism,PE),DVT与PE统称为静脉血栓栓塞症(venous thromboembolism,VTE),是同种疾病在不同阶段的表现形式[1]。全球范围内DVT和PE均有很高发病率,在美国每年约新发60万例VTE患者,发病率约1‰~2‰,其中30%患者表现为突发致死性PE[2-5]。亚洲国家VTE并不少见,以我国为例,随着诊疗水平的提高及居民健康意识的增加,其确诊数逐年上升,张伟等[6]对北京医院的研究分析表明,1962—2009年1650例尸检病例中PE检出率为3.4%。PE突出的高发病率(仅次于心、脑血管疾病)和高病死率(仅次于肿瘤、心肌梗死)[7],已成为导致院内患者非预期死亡的主要疾病。通过VTE的预防和及时诊治可以很大程度减少致死性PE的出现。对住院患者,尤其是行动不便的外科手术患者,一旦明确急性VTE,通常首选抗凝药物治疗,可以避免栓子蔓延,同时促使人体自身纤溶机制消融已产生的血栓[8]。然而当急性VTE患者出现抗凝禁忌或抗凝治疗失败时,置入下腔静脉滤器(inferior vena cava filters,IVCF)物理拦截下肢及盆腔静脉系统的血栓脱落成为预防PE的重要手段[9-11]

21世纪初IVCF的使用数量迅速增加,IVCF相关的并发症如倾斜、移位、断裂、血栓形成、下腔静脉穿孔等逐渐凸显[12],使得置入IVCF的争议日益增多[13],越来越多的国内外研究团队致力于新型IVCF研制以避免上述不良事件的发生。本研究从IVCF的临床应用现状及新型IVCF研究进展两个方面综合介绍了其发展历史、分型和缺陷,并针对现在研究的新型IVCF存在的问题,提出新的解决构想,展望对人体副作用小、无需二次手术取出的IVCF的开发,早日投入临床使用。

1 IVCF 临床应用现状

应用外科技术预防血栓脱落的历史可追溯到19 世纪30年代[14],股静脉或下腔静脉缝扎、折叠、夹闭等术式相继提出并使用,但因其明显改变了正常血流动力学特征及术后的高病死率被淘汰。1967年Mobin-Uddin滤器的上市揭开了下腔静脉腔内治疗的序幕,经过半个多世纪的探索,逐渐研发出由不同材料制成的、形状各异的IVCF。目前临床应用的IVCF多由镍钛合金制成,具有伞形,梭形,螺旋形等结构,在放射线或超声指引下经皮穿刺送入下腔静脉预定位置后恢复原始形状,通过网状过滤结构捕获血凝块[15]。根据使用情况,可分为永久型、临时型及可选择回收型IVCF。

永久型IVCF虽有效拦截血栓降低了致死性PE的患病率,但置入人体后除非手术切开腔静脉否则无法取出,患者需终生接受抗凝治疗,同时置入的滤器远期断裂、移位、栓塞、症状性下腔静脉穿孔等出现率也较高[16]。据报道,滤器穿透下腔静脉会导致胰腺炎、脓肿形成、十二指肠出血、主动脉损伤、输尿管损伤和脊柱损伤等[17-20],导致使用永久型IVCF的患者最终病死率没有下降[21]。因此,既可有效拦截血栓、又能在适当时间内取出(研究分析显示在植入后29~54 d内取出获益[22])的可回收型IVCF逐渐成为临床应用的主流,永久型IVCF的治疗时代已经结束。

临时型IVCF通过与外部的导管和固定设备相接,便于回收且对下腔静脉损伤较小,但其连接导管长期留置且与外界相通,增加了感染机会,并且一项对照研究发现其疗效并不优于单纯抗凝治疗[23],临床应用较少。目前美国食品药品监督管理局(Food and Drug Administration,FDA)仅批准了一款临时型IVCF(Angel Catheter)上市使用[24],适用于重症患者的床旁置入,同时可用于输液。

可回收型IVCF添加了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。但使用时需注意滤器若长期滞留体内,易通过炎性刺激等激发血管内皮过度增生,使得IVCF回收钩或支撑臂嵌入静脉壁,甚至滤器断裂、穿透腔静脉壁[25-27],强行取出时可致血管壁撕裂,引起严重并发症,这时需要使用复杂的技术(例如应用支气管钳、导丝成袢技术、激光辅助去除以及腹腔镜手术)将其收回[17,28-30]。FDA曾于2010年和2014年分别发表声明建议临床医生当患者VTE高危期过后及时取出滤器,以减少此类并发症,虽然此指南发布后滤器的使用量有所下降,但是可回收型IVCF的取出率仍然很低,据报道,美国2012年滤器的取出率为6.9%而2016年上升到22.1%,2021年一项单中心统计结果显示回收率仅上升为31.4%[31-34]。另外,有研究[35-36]表明患者依从性低、不能坚持随访也限制了IVCF的回收率。近年来我国医院每年在临床中使用可回收型IVCF约5万个以上,但国内尚无有关平均回收率的统计结果[37-38]。慈红波等[39]对108例置入IVCF的患者进行了单中心回顾性分析,通过采用抓捕器圈套取出、Loop技术及配合活检钳技术最终取出成功率为93.5%,其中滤器取出失败的主要原因为滤器倾斜导致滤器回收钩贴壁。我国单中心IVCF取出率较高的原因与多种辅助取出技术的应用有关,但其研究局限性为样本量较少,未来需进行多中心的大样本统计分析以得出平均回收率。可回收型IVCF除外目前回收率不高和一定的回收手术并发症缺陷之外,二次手术也增加了患者的经济负担和手术医生的射线曝光量,其发展应用进入瓶颈阶段,无需再次手术取出的IVCF成为研究的目标。

2 新型IVCF 的研究动态

2.1 药物洗脱IVCF

基于心脏介入治疗的启发,研究者们认为使用例如抗平滑肌增生、抗凝、抗炎等药物涂覆的载药下腔静脉滤器(Drug-Eluting IVCF)会像药物洗脱支架一样降低血管局部的炎性应答、阻止血管内膜的过度增生,延长IVCF的留置时间并便于回收,从而推动IVCF的进一步发展。基质金属蛋白酶(MMP)在上述过程中起关键作用,研究[40-41]将MMP抑制剂(MMPI)与聚乳酸-乙醇酸的混合溶液喷涂在可回收IVCF表面,通过IVCF支撑柱与下腔静脉壁接触部位缓慢释放MMPI,抑制MMP活性,从而抑制平滑肌细胞迁移,减少新内膜增生,并在动物模型体内证实其可有效增加管腔面积,预防血栓形成。最新的研究在滤器传统的血栓拦截功能基础上也取得了突破,Faltas等[42]设想使用涂有针对循环肿瘤细胞表面标志物特异性抗体的药物洗脱IVCF将吸引并裂解癌细胞,理论上减少肿瘤细胞通过静脉系统的血源性播散,这一假说赋予了IVCF新的功能,但目前未见进一步的研究报道。

2.2 可转换IVCF

可转换IVCF的设计理念为当VTE高危风险期过后,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IVCF远期并发症。Gao等[43]使用医用不锈钢丝设计并制作可转换IVCF主体结构(包括固定臂与过滤丝),并制成可降解L-丙交酯-ε-己内酯聚合物开关以束缚过滤丝构成锥形滤网结构,在犬模型体内研究中无需二次手术干预(共聚物开关降解后,束缚作用消失)即可自我转换为下腔静脉支架,实现75.5%的平均血栓捕获效率。一款2017年获得FDA批准的Sentry过滤器,主体为镍钛合金支架,具有可降解的聚对二氧环烷酮约束装置,可在PE高风险时期提供过滤功能,并在置入60 d后降解约束装置完成形状转换。一项纳入129例DVT或PE患者的多中心研究[44]显示,在长达12个月的随访中,96.4%的患者观察到Sentry过滤器成功转换,且所有病例未出现症状性PE。最新一款已临床应用的VenaTech CIVCF,多中心的回顾性研究[45]表明,在149例患者中置入VenaTech滤器,6个月后64.4%的患者渡过了VTE高风险期并尝试了滤器转化,成功率96.9%,转换组的滤器相关并发症也明显低于非转换组,但其转换需通过介入操作取出过滤器约束帽,并且上述可转换IVCF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。

2.3 生物可降解IVCF

生物可降解材料已广泛应用于医用缝线、药物释放体系、组织工程等领域,全吸收式可降解冠脉支架已进入临床研究阶段,被认为开启了冠脉介入治疗的新篇章。生物可降解IVCF可完全被机体吸收,避免了二次手术,成为国内外学者研究的热点。Yang等[46]运用左旋聚乳酸(PLLA)制备了一款沙漏状可降解IVCF,通过导管释放后可利用材料的形状记忆效应实现自我膨胀,并具有足够的径向支撑力,体外降解实验显示滤器可在6个月内保持原始的尺寸和结构,之后逐步降解,但人体内环境相对比较复杂,滤器在体内的降解过程仍需进一步研究。Zhang等[47]利用聚乙醇酸制成锥形过滤部分,聚己内酯为原料构成支架部分,设计了一款可降解IVCF,在超声引导下置入10只犬模型体内,全部实验犬存活6周后切除置入段下腔静脉行大体标本检查发现90%的滤网已完全降解,管壁无明显狭窄,但组织学检查见血管内膜和中膜明显增厚,显示强烈的炎症反应。Eggers等[48-51]采用聚二恶烷酮制备了可完全降解IVCF,在体外模拟循环系统及猪模型中验证了其具备优良的生物相容性和栓子捕获效率,可在至少5周保持足够的抗张强度以预防PE的发生,并且首次前瞻性的对8例VTE高危患者置入了可吸收IVCF,在整个研究进程中未发生PE及IVCF相关不良事件,临床有效率100%。这些说明了可降解IVCF的临床应用潜力,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,从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。

3 新型IVCF 的结构设计

IVCF阻拦血栓的功效依赖于结构设计,其结构也影响下腔静脉血流动力学。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研究提供了更有效的方法。Feng等[52]使用有限元技术和计算流体力学探究了新型可转换IVCF在血管置入和变形过程中,滤器结构与滤器变形行为、血管壁应力分布和滤器支撑刚度的相互作用机理和影响,研究结果表明在过滤器转化为支架之前,更容易导致血管壁损伤,而转换之后滤器与血管的应力作用以及血流动力学影响均有所减少,并在动物模型体内验证了其模拟过程的准确性。杨彩红等[53]通过对支撑杆数目为8、10、12的IVCF模型进行径向支撑力测试,研究显示其支持力随支撑杆数目的添加而减小,自扩张性能则与之相反。这一研究方法将为新型IVCF的结构优化设计提供更科学的参考与理论依据。

4 小结与展望

IVCF长期留置体内引发的一系列严重并发症已经受到国内外临床医生的广泛关注,以至于美国胸科医师学会(ACCP)发布的第10版VTE抗栓治疗指南以及中华医学会外科学分会血管外科学组制定的第3版深静脉血栓形成的诊断和治疗指南中均提到不推荐对单纯抗凝治疗的急性DVT或PE患者常规应用IVCF,但指南对IVCF预防和减少PE发生的作用予以了肯定,因此IVCF临床应用的关键在于严格把握其植入适应证。目前指南推荐的绝对适应证为:抗凝治疗有禁忌或有并发症,或在充分抗凝治疗的情况下仍发生PE者;相对适应证为:⑴髂、股静脉或下腔静脉内有漂浮血栓;⑵急性DVT拟行导管接触性溶栓(CDT)、经皮机械性血栓清除术(PMT)或手术取栓等血栓清除术者,具有急性DVT、PE高危因素的行腹部、盆腔或下肢手术的患者。

为减少滤器相关的远期并发症,临床应用首选可回收型IVCF,但因其较低的取出率、需要二次侵入性操作以及增加了患者经济负担等缺陷饱受争议。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。综上所述,我们认为新型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。

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Application and research progress of inferior vena cava filters

QU Ruisheng1,ZHOU Yanyi1,ZHANG Yaoming2,ZHOU Dong1

(1.Department of Vascular Surgery,Lanzhou University Second Hospital,Lanzhou 730030,China;2.Lanzhou Institute of Chemical Physics,Chinese Academy of Sciences,Lanzhou 730030,China)

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.

Key words Venous Thromboembolism;Vena Cava Filters;Review

中图分类号:R654.3

doi:10.7659/j.issn.1005-6947.2021.06.012

http://dx.doi.org/10.7659/j.issn.1005-6947.2021.06.012

Chinese Journal of General Surgery,2021,30(6):715-722.

基金项目:甘肃省兰州市科技发展指导性计划基金资助项目(2019-ZD-49)。

收稿日期:2021-01-19;

修订日期:2021-05-15。

作者简介:屈睿升,兰州大学第二医院住院医师,主要从事周围血管疾病腔内治疗方面的研究。

通信作者:周栋,Email:13919951166@139.com

CLC number:R654.3

(本文编辑 姜晖)

本文引用格式:屈睿升,周晏仪,张耀明,等.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

Cite this article as:Qu RS,Zhou YY,Zhang YM,et al.Application and research progress of inferior vena cava filters[J].Chin J Gen Surg,2021,30(6):715-722.doi:10.7659/j.issn.1005-6947.2021.06.012