asdpfo封堵器血栓形成的認(rèn)識(shí)

廣西醫(yī)科大學(xué)第一附屬醫(yī)院伍偉鋒ASD/PFO封堵器血栓形成的認(rèn)識(shí)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封堵器血栓形成的臨床診斷封堵器血栓形成臨床診斷主要依靠超聲心動(dòng)圖，特別是經(jīng)食管超聲心動(dòng)圖（TEE）超聲心動(dòng)圖特征為封堵器表面新出現(xiàn)的非平面性異?；芈?，并且該結(jié)構(gòu)部分可隨血流而飄動(dòng)

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封堵器血栓形成的發(fā)生率不同種類ASD/PFO封堵器血栓形成的發(fā)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等報(bào)道使用ASDOS封堵器139名患者中有9名血栓形成，血栓發(fā)病率6.5%Buttoned封堵器27名患者中有3名血栓形成，血栓發(fā)病率11.1%封堵器種類n應(yīng)檢TEE人數(shù)(n)實(shí)際TEE比例(%)血栓發(fā)生率(%,n)6個(gè)月4周6個(gè)月4周6個(gè)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與CardioSEAL、StarFLEX、PFO-Star之間血栓形成率有顯著性差異（p<0.05）（資料來(lái)自CardiovascularCenterFrankfurt,SanktKatharinen,Frankfurt,Germany）最近Jeffrey等為了回顧美國(guó)FDA從2002年開(kāi)始準(zhǔn)入的２種ASD/PFO封堵器（AGA和NMT）嚴(yán)重并發(fā)癥發(fā)生情況搜索了2002-2004年MEDLINE和MAUDE的AGA和NMT公司的ASD/PFO封堵器的嚴(yán)重并發(fā)癥文獻(xiàn)與數(shù)據(jù)庫(kù)資料(MAUDE:制造商和用戶的器械使用狀況數(shù)字庫(kù))（資料來(lái)自CongenitHeartDis.2007;2:256–264[７]）MEDLINEsearchusingtheMeSHterms“Atrialseptaldefectclosure,”“Amplatz,”“Deviceclosure,”and“CardioSEAL”identifiedpotentialstudiescoveringthe3-yearperiodofdeviceusagetobeanalyzedWelimitedoursearchtoarticleswritteninEnglishconcentratedonthelargercaseseries,giventhatthiswouldprovideamoreaccuratecomplicationrate.Atotalof12publicationswereselectedreviewedfortheincidence,type,andoutcomeofdeviceclosurecomplications結(jié)果發(fā)現(xiàn)封堵器血栓形成及由此而引起的血栓栓塞是三大嚴(yán)重并發(fā)癥之一在MAUDE中NMT公司的Star-FLEX及CardioSEAL，推算的發(fā)生率為0.2%AGA公司產(chǎn)的ASO僅為0.06%。MEDLINE文獻(xiàn)中NMT公司的封堵器血栓形成發(fā)生率為：Star-FLEX5.7%、CardioSEAL7.1–22%AGA公司產(chǎn)的ASO僅了１例表2美國(guó)FDA的MAUDE數(shù)據(jù)庫(kù)(2002-2004年)兩種封堵器并發(fā)癥報(bào)告對(duì)比

EM,封堵器栓塞/移位脫落；ER,封堵器磨蝕心臟/心包積液；TE,血栓栓塞；AR,心律失常；CVA,腦卒中Amplatzer(R)AtrialSeptalOccluder(ASO)(AGAMedicalCorp.,GoldenValley,MN,USA)CardioSEAL(R)SeptalOccluder(CS)(NMTMedical,Inc.,Boston,MA,USA)*來(lái)自廠家公布的數(shù)據(jù)，?來(lái)自廠家內(nèi)部的數(shù)據(jù)封堵器來(lái)源總例數(shù)并發(fā)癥類型總例數(shù)主要類型例數(shù)相關(guān)死亡例數(shù)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例心臟病發(fā)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相關(guān)文獻(xiàn)報(bào)道的并發(fā)癥匯總作者封堵器并發(fā)癥來(lái)源數(shù)量文獻(xiàn)涉及類型總數(shù)（%）主要類型相關(guān)死亡數(shù)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作者封堵器并發(fā)癥來(lái)源數(shù)量文獻(xiàn)涉及類型總數(shù)（%）主要類型相關(guān)死亡數(shù)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封堵器血栓形成的臨床危險(xiǎn)因素表４單中心ASD/PFO封堵器血栓形成的潛在危險(xiǎn)因素分析

危險(xiǎn)因素?zé)o血栓形成病例有血栓形成病例p值心房顫動(dòng)66/980(6.2%)4/20(20%)<0.05封堵術(shù)后即時(shí)殘余分流287/980(29%)3/20(15%)NS永存房間隔瘤13/980(1.3%)4/20(20%)<0.01金屬裝置斷裂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平均年齡47歲48歲NS性別男女412/980(42%)568/980(58%)9/20(45%)11/20(55%)NSNS高血壓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華法林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魚(yú)精蛋白798/980(81%)19/20(95%)NS封堵器血栓形成的臨床轉(zhuǎn)歸JAmCollCardiol2004;43:302–9ThrombusonaCardioSealoccluderLeftatrialthrombusformationwasdetectedat1monthfollow-upina45yearoldmalewithoutthrombophiliaunderananticoagulationtherapywithcoumadine(arrow).Afterashortperiodofintravenouslyadministeredheparin,anticoagulationwaschangedtoASAplusClopidogrel.At2monthsfollow-upthrombussizehadclearlyregressed(arrows)andafteradditional4weeksithadcompletelyresolved.(CurrentPharmaceuticalDesign,2006,12,1287