（优质课件）左心耳封堵

左心耳封堵 1 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 2 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 3 死亡率 住院率 脑卒中 生活质量 运动耐力 心功能 房颤的危害 4 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 5 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 6 LAA解剖 漩涡流速 左心耳易形成血栓原因 7 左心耳的形态 卒中风险 8 房颤卒中的预防 出血影响因素多依从性差OAC费用 9 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 10 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 11 PLAATO ev3Inc PercutaneousLeftAtrialAppendageTranscatheterOcclusion 第一种封堵LAA装置 2002 15 32mm 12 Watchman BostonScientific Natick Massachusetts 14F 13 AmplatzercardiacplugSt JudeMedical St Paul Minnesota ACP Amulet 14 LifetechLAmbreTMDevice 16 36mm 8 10French ahook embeddedumbrellaacoverconnectedwithashortcentralwaistwaist anarticulating compliantconnectioncoveris4to6mmlargerdistalumbrellacomprises8clawswithindividualstabilizinghookscompletecollapseandrepositioning 15 AFlexibleSelf ApposingLAACDevice Ultrasept CardiaInc Eagan MN ChengY etal CatheterCardiovascInterv 2013 12FdeliverycatheterSizeofdistalsideofthedevice16 20 and24mmFlexiblearticulation self orienttothecardiacwallProximalsailis4mmlargerthedistalbulbindiameters20 24 and28mmSixpairs total12 ofhooksseveraldifferentcomponents 16 其他用于左心耳封堵器械 KanthanA etal Heart LungandCirculation 2013 ChiamP etal TheJournalofinvasivecardiology 2008 20 4 E109 17 左心耳封堵器械植入过程 18 左心耳封堵器械植入过程 19 20 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 21 BlockPCetal JACC CardiovascularInterventions 2009 2 7 594 600 PercutaneousLeftAtrialAppendageOcclusionforPatientsinAtrialFibrillationSuboptimalforWarfarinTherapy 5 YearResultsofthePLAATO PercutaneousLeftAtrialAppendageTranscatheterOcclusion Study 61 64patients9sitesintheU S And1Canadiansite November18 2003 22 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 23 24 InitialWorldwideExperienceWiththeWATCHMANLeftAtrialAppendageSystemforStrokePreventioninAtrialFibrillation PeterB Sicketal JAmCollCardiol2007 49 1490 5 open labelnonrandomizedpilotstudy 25 ConclusionsLAAocclusionwiththeWATCHMANdeviceappearstobesafewithpreliminaryresultsconsistentwithlowstrokeriskdespitediscontinuationofanticoagulation 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 26 DavidRHolmes etal Lancet2009 374 534 42 PROTECTAF 27 Thus ourstrategyforclosingtheLAAwasnon inferiortowarfarintherapyintermsoftheprimaryefficacyendpointofallstroke cardiovasculardeath andsystemicembolism Althoughthereisahigherinitialsafetyeventratefordeviceimplantation adverseeventswerewithoutlong termsequelaeformostpatients ClosureoftheLAAmightprovideanalternativestrategytochronicwarfarintherapyforstrokeprophylaxisinpatientswithnonvalvularatrialfibrillation Interpretation 28 Circulation 2011 123 417 424 29 30 31 ConclusionsTheLAAclosuretrialshavedemonstratedthat complicationsassociatedwithWatchmanimplantationaretypicallyclusteredearlyintheperiproceduralperiodandsignificantlydecreaseinfrequencywithoperatorexperience Inaddition despiteahigheroverallcomplicationrateassociatedwithLAAclosurethanwarfarintreatment thefunctionalimpactoftheseeventsfavorsLAAclosure Together thesedatasuggestafavorablesafetyprofileforWatchmanimplantation 32 LeftAtrialAppendageClosureWiththeWatchmanDeviceinPatientsWithaContraindicationforOralAnticoagulation Reddyetal JACCVol 61 No 25 2013 33 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 34 CONCLUSION TheimplantationoftheACPdeviceisafeasiblemethodforpercutaneousocclusionoftheLAA ParkJW CatheterCardiovascInterv 2011Apr1 77 5 700 6 BACKGROUND 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 andlossoftheimplantinthevenoussysteminonepatient 35 LeftatrialappendageclosurewithAmplatzercardiacplugforstrokepreventioninatrialfibrillation InitialAsia Pacificexperience BACKGROUND LAAisthemainsourceofleftatrialthrombusthatcausesstrokeinpatientswithNVAF Thisstudyreportedtheinitialsafety feasibility and1 yrclinicaloutcomesfollowingACPimplantationinAsia Pacificregion METHODS TwentyNVAFpatients 16males age68 9yr withhighriskfordevelopingcardioembolicstroke CHADS2score 2 3 1 3 andcontraindicationstowarfarinreceivedACPimplantsfromJune2009toMay2010 Patientsreceivedgeneralanesthesia n 9 orcontrolledpropofolsedation n 11 andtheprocedureswereguidedbyfluoroscopyandtransesophagealechocardiography TEE Clinicalfollow upwasarrangedat1monthandthenevery3monthsafterimplantation whereas aTEEwasscheduledat1monthuponcompletionofdualanti platelettherapy LamYY etal CatheterCardiovascInterv 2012Apr1 79 5 794 800 36 Conclusions OurpreliminarydatasuggestedLAAclosurewithACPissafe feasiblewithencouraging1 yrclinicaloutcomes Further areneededtoconfirmtheefficacyofthisdevice RESULTS TheLAAwassuccessfullyoccludedin19 20patients 95 attwoAsiancenters Oneprocedurewasabandonedbecauseofcatheter relatedthrombusformation Othercomplicationsincludedcoronaryarteryairembolism n 1 andTEE attributedesophagealinjury n 1 Themedianproceduralandfluoroscopictimeswere79 IQR 59 100 and18 IQR12 27 minutes respectively Themeansizeofimplantwas23 6 3 1mm Theaveragehospitalstaywas1 8 1 1days Follow upTEEshowedalltheLAAorificesweresealedwithoutdevice relatedthrombusformation Nostrokeordeathoccurredatameanfollow upof12 7 3 1months LeftatrialappendageclosurewithAmplatzercardiacplugforstrokepreventioninatrialfibrillation InitialAsia Pacificexperience 37 PercutaneousLeftAtrialAppendageClosureWiththeAMPLATZERCardiacPlugDeviceinPatientsWithNonvalvularAtrialFibrillationandContraindicationstoAnticoagulationTherapy MarinaUrenaetal JACC 2013 62 No 2 52patientswithNVAFcontraindicationstoOAC