asdpfo封堵器血栓形成的认识

广西医科大学第一附属医院伍伟锋ASD/PFO封堵器血栓形成的认识IntroductionPercutaneousASDclosure(1974,King)Closureofatrialseptalcommunications,ASDandPFOfromanopensurgicaltechniquetopercutaneous,catheter-based,closuredevicesCurrentlyavailabledeviceswithintheUnitedStatesforpercutaneousclosureofatrial-leveldefectswithinrandomizedcontrolledtrialsInterventionalCatheterizationinAdultCongenitalHeartDisease.Circulation2007;115;1622-1633

Complicationscanbeunknownorunder-estimatedpriortogeneraluserelativelysmallandcarefullselectedpatientpopulationshortdurationoffollow-uplimitedindicationsToreviewtherateofrare,butpotentiallyseriouscomplications

highlighted3majorcomplicationsdeviceembolization(EM)deviceerosion(ER)thrombusformationDeviceembolizationEmbolizationrateAGAdevice0.5%,70%ofthedevicessuccessfullyretrievedpercutaneouslyNMTdevice4%inEuropeanstudies1–2%world-wide.LeviDS,MooreJW.Embolizationandretrievaloftheamplatzerseptaloccluder.CatheterCardiovascInterv.2004;61:543–547DeviceerosionNMTdevicesonly1casereportAGAdevicesNumerouscasereportsIntheUnitedStatesestimated9000implants,14eventswerereportedwithconfirmederosionsand3deaths

0.1%incidenceofthiscomplication,buta20%mortalityriskwithitoccursJeffreyW.Delaney,MD,JenniferS.Li,MD,andJohnF.Rhodes,CongenitHeartDis,2007,2:256–264.

2-DandcolorDopplerTTEviewsofAorto-atrialfistula.AmJCardiol.96:1607–1609Intraoperativephoto,AGAdeviceinplaceandarrowtofistula.AmJCardiol.96:1607–1609

ThrombusformationASD/PFO封堵器血栓形成的临床诊断封堵器血栓形成临床诊断主要依靠超声心动图，特别是经食管超声心动图（TEE）超声心动图特征为封堵器表面新出现的非平面性异常回声，并且该结构部分可随血流而飘动

FigureATransesophagealechocardiographyfour-chamberview:left-sidedmobilethrombusattachedtoaStarFLEXoccluderdetectedfourWeeksaftercatheterclosure.FigureBTransesophagealechocardiographyshortaxis:right-andleft-sidedimmobilethrombussurroundinganASDOSOccluderdetectedfourweeksaftercatheterclosure.FigureCTransesophagealechocardio-graphyshort-axis:largemobilethrombus(30×18mm)Attachedtotherightatrialwall(withoutdirectcontacttotheASDOSdevice)detectedoneyearaftercatheterclosure.JAmCollCardiol,2004,43:302-309FigureAshorttransesophagealviewofsmallmobileleft-sidedthrombionaStarFLEXoccluder.Duringsurgery,theabsenceoftheleft-sidedthrombi.Butdetectionofaright-sidedthrombus(8mm)notdiagnosedbeforewasremovedtogetherwiththedevice.

JAmCollCardiol,2004,43:302-309ASD/PFO封堵器血栓形成的发生率不同种类ASD/PFO封堵器血栓形成的发生率

LaRosee等描述38例ASD患者有3例（10.5%）血栓形成，60例PFO患者有8例（13.3%）血栓形成LambertV等报道使用ASDOS封堵器139名患者中有9名血栓形成，血栓发病率6.5%Buttoned封堵器27名患者中有3名血栓形成，血栓发病率11.1%封堵器种类n应检TEE人数(n)实际TEE比例(%)血栓发生率(%,n)6个月4周6个月4周6个月Rashkind11100%100%0%0%ButtonedDevice525267%69%0%0%ASDOS424266%83%3.6%(n=1)0%AngelWings30300%97%0%3.3%(n=1)CardioSEAL272752%93%7.1%(n=1)*0%Star-FLEX14211174%70%5.7%(n=6)*0%Amplatzer41837578%70%0%*0.3%(n=1)PFO-Star12712760%66%6.6%(n=5)*1.5%(n=1)Helex16113876%80%0.8%(n=1)0%JAmCollCardiol,2004,43:302-309Amplatzer与CardioSEAL、StarFLEX、PFO-Star之间血栓形成率有显著性差异（p<0.05）（资料来自CardiovascularCenterFrankfurt,SanktKatharinen,Frankfurt,Germany）最近Jeffrey等为了回顾美国FDA从2002年开始准入的２种ASD/PFO封堵器（AGA和NMT）严重并发症发生情况搜索了2002-2004年MEDLINE和MAUDE的AGA和NMT公司的ASD/PFO封堵器的严重并发症文献与数据库资料(MAUDE:制造商和用户的器械使用状况数字库)（资料来自CongenitHeartDis.2007;2:256–264[７]）MEDLINEsearchusingtheMeSHterms“Atrialseptaldefectclosure,”“Amplatz,”“Deviceclosure,”and“CardioSEAL”identifiedpotentialstudiescoveringthe3-yearperiodofdeviceusagetobeanalyzedWelimitedoursearchtoarticleswritteninEnglishconcentratedonthelargercaseseries,giventhatthiswouldprovideamoreaccuratecomplicationrate.Atotalof12publicationswereselectedreviewedfortheincidence,type,andoutcomeofdeviceclosurecomplications结果发现封堵器血栓形成及由此而引起的血栓栓塞是三大严重并发症之一在MAUDE中NMT公司的Star-FLEX及CardioSEAL，推算的发生率为0.2%AGA公司产的ASO仅为0.06%。MEDLINE文献中NMT公司的封堵器血栓形成发生率为：Star-FLEX5.7%、CardioSEAL7.1–22%AGA公司产的ASO仅了１例表2美国FDA的MAUDE数据库(2002-2004年)两种封堵器并发症报告对比

EM,封堵器栓塞/移位脱落；ER,封堵器磨蚀心脏/心包积液；TE,血栓栓塞；AR,心律失常；CVA,脑卒中Amplatzer(R)AtrialSeptalOccluder(ASO)(AGAMedicalCorp.,GoldenValley,MN,USA)CardioSEAL(R)SeptalOccluder(CS)(NMTMedical,Inc.,Boston,MA,USA)*来自厂家公布的数据，†来自厂家内部的数据封堵器来源总例数并发症类型总例数主要类型例数相关死亡例数AGA12000*所有8873（其中34例EM，29例ER，6例TE，2例AR，2例BE）8例死亡（其中4例ER，3例猝死，1例心脏病发作）NMT8950†所有4024（其中10例TE,9例EM,5例ER）2例死亡（其中1例CVA，1例ER）表3MEDLINE相关文献报道的并发症汇总作者封堵器并发症来源数量文献涉及类型总数（%）主要类型相关死亡数DuASO442所有34(7.2)7（4EM,2AR,1TE）0ChessaASO258所有23(8.9)85EM,2ER,1TE1NMT159所有13(8.1)55EMHongASO49所有1(2)00LeviASO3824EM21(0.5)60WangASO197所有14(7.1)64ER,1EM,1AR0AminASO9000*ER14(0.1)14３PreventzaASO25000*ER16(0.6)161KaulitzNMT72所有18(25)00CarminettiNMT325所有35(10.8)1212EM0KrumsdorfASO418TE000NMT169TE7(6.6)30ButeraASO153所有6(3.9)31ER,1EM,1AR0NMT121所有6(5)33EM0AnzaiASO36TE０００NMT30TE5(17.6)１０作者封堵器并发症来源数量文献涉及类型总数（%）主要类型相关死亡数DuASO442所有34(7.2)7（4EM,2AR,1TE）0ChessaASO258所有23(8.9)85EM,2ER,1TE1NMT159所有13(8.1)55EMKrumsdorfASO418TE000NMT169TE7(6.6)30NMT121所有6(5)33EM0AnzaiASO36TE０００NMT30TE5(17.6)１０ASD/PFO封堵器血栓形成的临床危险因素表４单中心ASD/PFO封堵器血栓形成的潜在危险因素分析

危险因素无血栓形成病例有血栓形成病例p值心房颤动66/980(6.2%)4/20(20%)<0.05封堵术后即时残余分流287/980(29%)3/20(15%)NS永存房间隔瘤13/980(1.3%)4/20(20%)<0.01金属装置断裂47/980(4.8%)3/20(15%)NS蛋白C缺乏8/456(1.8%)0/20(0%)NS蛋白S缺乏9/456(2%)0/20(0%)NS活化蛋白C抵抗25/456(5.5%)0/20(0%)NS平均年龄47岁48岁NS性别男女412/980(42%)568/980(58%)9/20(45%)11/20(55%)NSNS高血压228/980(23%)3/20(15%)NS冠心病51/980(5%)0/20(0%)NS糖尿病37/980(4%)0/20(0%)NS华法林95/980(10%)3/20(15%)NS阿斯匹林505/980(52%)6/20(30%)NS阿斯匹林+氯吡格雷380/980(39%)11/20(55%)NS鱼精蛋白798/980(81%)19/20(95%)NS封堵器血栓形成的临床转归JAmCollCardiol2004;43:302–9ThrombusonaCardioSealoccluderLeftatrialthrombusformationwasdetectedat1monthfollow-upina45yearoldmalewithoutthrombophiliaunderananticoagulationtherapywithcoumadine(arrow).Afterashortperiodofintravenouslyadministeredheparin,anticoagulationwaschangedtoASAplusClopidogrel.At2monthsfollow-upthrombussizehadclearlyregressed(arrows)andafteradditional4weeksithadcompletelyresolved.(CurrentPharmaceuticalDesign,2006,12,1287