左心耳封堵

举“卒”轻重话左心耳封堵背景左心耳封堵器械研发现状左心耳封堵器械临床试验左心耳封堵存在的问题房颤发病率在65～85岁年龄组最高不同性别与年龄的房颤发病率房颤的发病率死亡率住院率脑卒中生活质量运动耐力心功能房颤房颤的危害10%45%45%房颤卒中的危害性轻度中到重度致死性非瓣膜性房颤卒中90%以上的栓子来自左心耳左心耳的解剖&作用•胚胎时期原始左心房残余•狭长、弯曲管状形态•内有梳状肌、肌小梁，小梁间有缝隙•颈部位于左上肺静脉和二尖瓣瓣环之间•回旋支靠近左心耳开口基底部▪压力和容量负荷的调节作用▪电生理作用▪内分泌作用分泌ANP、BNP▪介导口渴调节LAA解剖漩涡流速AF左房压力左房LAA容积LAA充盈速度排空速度LAA口直径LAA有效收缩左心耳易形成血栓原因左心耳的形态&卒中风险左心耳封堵恢复维持窦性心律（导管消融）外科结扎CHADS2药物抗栓房颤卒中的预防.出血影响因素多依从性差OAC费用复发率高仍需服药微创复杂手术创伤术后再通背景左心耳封堵器械研发现状左心耳封堵器械临床试验左心耳封堵存在的问题左心耳封堵术使用特制的封堵器闭塞左心耳，从而达到预防房颤血栓栓塞的目的外科术中闭合左心耳可明显减少房颤患者发生卒中事件PLAATO（ev3Inc)PercutaneousLeftAtrialAppendageTranscatheterOcclusion第一种封堵LAA装置（2002）15-32mmWatchman(BostonScientific,Natick,Massachusetts)14FAmplatzercardiacplugSt.JudeMedical，St.Paul，MinnesotaACPAmuletLifetechLAmbreTMDevice16–36mm8–10Frenchahook-embeddedumbrellaacoverconnectedwithashortcentralwaistwaist=anarticulating,compliantconnectioncoveris4to6mmlargerdistalumbrellacomprises8clawswithindividualstabilizinghookscompletecollapseandrepositioningAFlexibleSelf-ApposingLAACDeviceUltrasept™(CardiaInc.,Eagan,MN)ChengY,etal.CatheterCardiovascInterv.2013.12FdeliverycatheterSizeofdistalsideofthedevice16,20,and24mmFlexiblearticulation,self-orienttothecardiacwallProximalsailis4mmlargerthedistalbulbindiameters20,24,and28mmSixpairs(total12)ofhooksseveraldifferentcomponents其他用于左心耳封堵器械KanthanA,etal.Heart,LungandCirculation.2013.ChiamP,etal.TheJournalofinvasivecardiology.2008;20(4):E109.左心耳封堵器械植入过程左心耳封堵器械植入过程背景左心耳封堵器械研发现状左心耳封堵器械临床试验左心耳封堵存在的问题BlockPCetal.JACC:CardiovascularInterventions.2009;2(7):594-600PercutaneousLeftAtrialAppendageOcclusionforPatientsinAtrialFibrillationSuboptimalforWarfarinTherapy5-YearResultsofthePLAATO(PercutaneousLeftAtrialAppendageTranscatheterOcclusion)Study61/64patients9sitesintheU.S.And1Canadiansite.November18,2003..死亡7例，重症中风5例，小中风3例，可能的脑出血1例，心梗1例，心包压塞1例InitialWorldwideExperienceWiththeWATCHMANLeftAtrialAppendageSystemforStrokePreventioninAtrialFibrillationPeterB.Sicketal.JAmCollCardiol2007;49:1490–5open-labelnonrandomizedpilotstudyConclusionsLAAocclusionwiththeWATCHMANdeviceappearstobesafewithpreliminaryresultsconsistentwithlowstrokeriskdespitediscontinuationofanticoagulation.…inwhomanticoagulationcarriesahighriskoriscontraindicated,thesedevicesmayofferanattractivesolutiontotheAF-relatedemboliproblem…2例发生心脏压塞，1例发生空气栓塞，1例发生输送导丝断裂需外科手术取出。6个月，4例出现装置表面血栓，97.1％的患者在6个月内可停用华法林，随访2年时仅2例发生一过性脑缺血DavidRHolmes.etal.Lancet2009;374:534–42PROTECTAFThus,ourstrategyforclosingtheLAAwasnon-inferiortowarfarintherapyintermsoftheprimaryefficacyendpointofallstroke,cardiovasculardeath,andsystemicembolism.Althoughthereisahigherinitialsafetyeventratefordeviceimplantation,adverseeventswerewithoutlong-termsequelaeformostpatients.ClosureoftheLAAmightprovideanalternativestrategytochronicwarfarintherapyforstrokeprophylaxisinpatientswithnonvalvularatrialfibrillation.InterpretationCirculation.2011;123:417-424ConclusionsTheLAAclosuretrialshavedemonstratedthat,…,complicationsassociatedwithWatchmanimplantationaretypicallyclusteredearlyintheperiproceduralperiodandsignificantlydecreaseinfrequencywithoperatorexperience.Inaddition,despiteahigheroverallcomplicationrateassociatedwithLAAclosurethanwarfarintreatment,thefunctionalimpactoftheseeventsfavorsLAAclosure.Together,thesedatasuggestafavorablesafetyprofileforWatchmanimplantation.LeftAtrialAppendageClosureWiththeWatchmanDeviceinPatientsWithaContraindicationforOralAnticoagulationReddyetal.JACCVol.61,No.25,2013…theASAPregistryhasdemonstratedthattheWatchmandevicecanbesafelyimplantedwithoutawarfarintransition.Thatallowstheapplicationofthistherapytothepatientpopulationatgreatestclinicalneedforanalternativetooralanticoagulationtherapy:AFpatientsathighriskforstrokebutwithcontraindicationstosystemicoralanticoagulation….随访14.2月，有4例发生卒中，1例发生全身性栓塞，TEE记录6例发生装置相关性血栓。所观察到的缺血性卒中发生率为1.8％，意味着相较于阿司匹林单药治疗（7.1％）和阿司匹林联合终身氯吡格雷治疗（5.0％）降低了卒中发生75％和64％.CONCLUSION:TheimplantationoftheACPdeviceisafeasiblemethodforpercutaneousocclusionoftheLAA.ParkJW.CatheterCardiovascInterv.2011Apr1;77(5):700-6BACKGROUND:Inmostpatientswithatrialfibrillation(AF)andstroke,ThisstudydetailstheinitialexperiencewiththeAmplatzerCardiacPlug(ACP)inhumans.METHODS:Investigator-initiatedretrospectivepreregistrydatacollectiontoevaluateproceduralfeasibilityandsafetyupto24hrafterimplantationoftheACP,anitinoldevicedesignedforpercutaneoustrans-septalimplantationinLAAofpatientswithparoxysmal,permanent,orpersistentAF.RESULTS:In137of143patients,LAAocclusionwasattempted,andsuccessfullyperformedin132(96%).Therewereseriouscomplicationsin10(7.0%)patients(threepatientswithischemicstroke;twopatientsexperienceddeviceembolization,bothpercutaneouslyrecaptured;andfivepatientswithclinicallysignificantpericardialeffusions).Minorcomplicationswereinsignificantpericardialeffusionsinfour,transientmyocardialischemiaintwo,andlossoftheimplantinthevenoussysteminonepatientLeftatrialappendageclosurewithAmplatzercardiacplugforstrokepreventioninatrialfibrillation:InitialAsia-PacificexperienceBACKGROUND:LAAisthemainsourceofleftatrialthrombusthatcausesstrok