asdpfo封堵器血栓形成的認識

廣西醫(yī)科大學第一附屬醫(yī)院伍偉鋒ASD/PFO封堵器血栓形成的認識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圖，特別是經食管超聲心動圖（TEE）超聲心動圖特征為封堵器表面新出現的非平面性異常回聲，并且該結構部分可隨血流而飄動

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應檢TEE人數(n)實際TEE比例(%)血栓發(fā)生率(%,n)6個月4周6個月4周6個月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）（資料來自CardiovascularCenterFrankfurt,SanktKatharinen,Frankfurt,Germany）最近Jeffrey等為了回顧美國FDA從2002年開始準入的２種ASD/PFO封堵器（AGA和NMT）嚴重并發(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封堵器的嚴重并發(fā)癥文獻與數據庫資料(MAUDE:制造商和用戶的器械使用狀況數字庫)（資料來自CongenitHeartDis.2007;2:256–264[７]）MEDLINEsearchusingtheMeSHterms“Atrialseptaldefectclosure,”“Amplatz,”“Deviceclosure,”and“CardioSEAL”identifiedpotentialstudiescoveringthe3-yearperiodofdeviceusagetobeanalyzedWelimitedoursearchtoarticleswritteninEnglishconcentratedonthelargercaseseries,giventhatthiswouldprovideamoreaccuratecomplicationrate.Atotalof12publicationswereselectedreviewedfortheincidence,type,andoutcomeofdeviceclosurecomplications結果發(fā)現封堵器血栓形成及由此而引起的血栓栓塞是三大嚴重并發(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公司產的ASO僅為0.06%。MEDLINE文獻中NMT公司的封堵器血栓形成發(fā)生率為：Star-FLEX5.7%、CardioSEAL7.1–22%AGA公司產的ASO僅了１例表2美國FDA的MAUDE數據庫(2002-2004年)兩種封堵器并發(fā)癥報告對比

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)*來自廠家公布的數據，?來自廠家內部的數據封堵器來源總例數并發(fā)癥類型總例數主要類型例數相關死亡例數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相關文獻報道的并發(fā)癥匯總作者封堵器并發(fā)癥來源數量文獻涉及類型總數（%）主要類型相關死亡數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)癥來源數量文獻涉及類型總數（%）主要類型相關死亡數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因素表４單中心ASD/PFO封堵器血栓形成的潛在危險因素分析

危險因素無血栓形成病例有血栓形成病例p值心房顫動66/980(6.2%)4/20(20%)<0.05封堵術后即時殘余分流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魚精蛋白798/980(81%)19/20(95%)NS封堵器血栓形成的臨床轉歸JAmCollCardiol2004;43:302–9ThrombusonaCardioSealoccluderLeftatrialthrombusformationwasdetectedat1monthfollow-upina45yearoldmalewithoutthrombophiliaunderananticoagulationtherapywithcoumadine(arrow).Afterashortperiodofintravenouslyadministeredheparin,anticoagulationwaschangedtoASAplusClopidogrel.At2monthsfollow-upthrombussizehadclearlyregressed(arrows)andafteradditional4weeksithadcompletelyresolved.(CurrentPharmaceuticalDesign,2006,12,1287