中国TAVR的临床疗效和经验

中国TAVR的临床疗效和经验JunboGe,MD,FACC,FESC,FSCAIProfessorofMedicine/CardiologyChairman,ShanghaiInstituteofCardiovascularDiseasesDirector,Dept.ofCardiologyZhongshanHospital,FudanUniversityOctober2010，ourcentersuccessfullycompletedthefirstcaseofTAVRinChina（secondcaseofTAVRinAsia）usingaCoreValve•November2010,FuwaihospitalinBeijing(CoreValve)•February2011,301HospitalinBeijing(CoreValve)•May2011，ChanghaiHospitalinShanghai(Edwards)•Then,otherhospitalsChineseValvesVenus-AJ-valveVitaFlowVenus-A(HangzhouVenusMedicalequipmentsCo.Ltd.)•firstdomesticValve•Firstcase,September2011,FuwaiHospital•220cases•MaybeapprovedbyCFDAsoon(2016)Venus-A(HangzhouVenusMedicalequipmentsCo.Ltd.)Self-expandingValveNitonolframe,providingstrongradialforceininflowpartsupra-annulustri-leafletvalve,usingporcinepericardiumCoatedfilmoutsideinflowparttopreventparavalvularleakInitialresultsofVenus-Atrial•81casesofASwithprohibitiveorhighsurgicalrisk•5centersinChina,meanage:75years•Proceduresuccessesrate:96.3%，30daysall-causemortality:4.9%；pacemakerimplantationrate:20.75%•30daysfollow-up:symptomswererelieved,valvefunctionwasgood•Venus-AmaybeapprovedbySFDAin2016GaoRunlin，2014CHCJ-valve(SuzhouJiecheng,CO.)Trans-apicallyimplantedwithlargesheathSelf-expandingAutomaticpositioningwiththree“locatingfoots”alsosuitableforARpatients•Firstcase,March2014,HuaxiHospital•Completed120casesenrollmentin3heartcenter,withproceduresuccessesrateof95%,•trans-apicallyimplantedbysurgery•IncludedARpatients•MaybeapprovedbySFDAin2016J-valve(SuzhouJiecheng,CO.)VitaFlow(ShanghaiMicroportCO.)Self-expandingnitinolframeBovinepericardialleafletswithanti-calcificationtreatmentLargecellsforimprovedconformabilityandcoronaryaccessProlongedskirtbeyondinflowforbettersealingVavledesignVitaFlow(ShanghaiMicroportCO.)DeliverySystemSingleoperator,usercontrolledmotorizeddeploymentsystemCatheterdistalFlexfeaturefortrackabilityandalignmentCompatiblewithlowprofile16F-18FSheathProjectScheduleBenchtest&animalstudydone201420152016201720182019Firstinmandone（ShanghaiZhognshanHosital）Feasibilitystudydone(10cases)Safetyandeffectivenesstrial*CFDAsubmissionLaunchBaselineCharacteristicsCharacteristicMeanValue(N=41)Age(yrs)77.4Gender%Female56%STSScore(%)7.39%NYHAclassIINYHAclassIII/IV24.39%75.61%Aorticvalvebicuspidaorticvalve18/41normaltricuspid23/41Aorticvalvearea(cm2)0.616Meangradient(mmHg)61.5LVEF（%）57.32First41casesforVitaFlow(ShanghaiMicroportCO.)procedurePatients(n=41)ApproachTransfemoral36/41AscendingAorta1/41CarotidArtery4/41Valve-in-valve4/41ImplantedvalvesizeTAV2426/41TAV2715/41Devicesuccess41/41ProceduralInformation术中严重并发症：1例发生主动脉夹层术中死亡；1例右冠闭塞转外科搭桥；1例瓣环破裂转外科+支架瓣膜植入；1例转外科换生物瓣0(0/20)Outcomesat30Days（N=35）Event30DaysAllcausemortality1/35Devicesuccess35/35Majorstoke1/35Acutekidneyinjury0/35Majorbleeding0/35Vascularcomplication0/35Coronaryarteryocclusion1/35Newpacemakerimplantation1/35•初步技术推广应用显示：TAVR在我国患者中安全有效20hospitalsin9provincesAbout500casesValve:CoreValve(100cases),EdwardsSapienXT(14cases)、Venus-A(220Cases）,J-Valve（140cases）,VitaFlow-Valve（30）About1/3caseswerebicuspidaorticvalve(BAV)stenosisChinesepatients'characteristics(differentfromwesternCountry)HighproportionofBAVSeverecalcificationSmallperipherialarterydiameterMoreARpatientsthanASPercentageofBAVindifferentagegroupsChinesepatientsPanW,etal.ZhonghuaXinXueGuanBingZaZhi.2015;43(3):244-7.JilaihawiH,etal.CatheterCardiovascInterv.2015,Suppl1:752-61.ARismoreprevalentthanASinChineseelderlypopulationPropotionsofvalvediseaseinapatientscohortundergoingvalvesurgeryinalargeChineseheartcneter(GroupA:1991-2000;GroupB:2001-2010)白一帆.成人心脏瓣膜病外科治疗20年回顾及危险因素变迁.第二军医大学(长海医院)，2012.博士论文TAVR中国经验之——二叶式主动脉瓣（BAV）BAV患者TAVR的难点1.瓣膜难以完全打开。相对于三叶式，从力学的角度看，二叶式瓣膜球囊扩张时，瓣膜难以完全分开。导致球囊扩张效果不明显，并且瓣膜支架难以完全打开。术后瓣环常常呈椭圆形，长期可能影响瓣膜的功能。BAV患者TAVR的难点2.容易出现瓣周漏。BAV的瓣膜不对称、钙化重而不均匀等解剖学特点导致置入的瓣膜难以完全贴壁，容易导致瓣周漏。BAV患者TAVR的难点3.容易移位。瓣膜难以打开，受到挤压力更大，导致瓣膜容易向下移位。有报道显示BAV患者TAVR术后瓣膜移位的概率高达9.3％1YousefA,Internationaljournalofcardiology.2015;189:282-288BAV患者TAVR的难点4.常合并主动脉扩张、主动脉瘤，瓣膜支架的支撑点减少。BAV患者的TAVR策略——高位释放BAV患者的TAVR策略——高位释放BAV患者的TAVR策略——小一号瓣膜由于BAV的瓣膜常常难以完全打开，按照常规方法选择瓣膜往往出现瓣膜狭窄，跨瓣压差，且容易出现瓣膜被挤压移位针对BAV患者瓣膜尺寸的选择，虽没有明确的循证学依据，目前常经验性地采用“球囊实时测量”（balloonsizing）并结合CT测量指导下的“降低尺寸（downsizing）”策略，即在TAV瓣膜尺寸选择指南的基础上，选择小一号的瓣膜。我们的实践表明，选择合适大小的瓣膜可以提高手术操作过程中的可控性，使瓣膜移位、瓣周漏的发生率降低。AorticvalveannulusAverage24.5mmPerimeter:77.0mmArea:429.2mm2Maximumdiameter:29.5mmCase1选择24mm瓣膜！BAV患者的TAVR策略——个体化策略术前对患者进行超声心动图尤其是多层螺旋CT扫描检查，明确BAV的分型（0型、1型、2型、功能性二瓣化）、瓣环的椭圆程度、瓣叶的对称性、瓣叶的钙化程度和分布、冠状动脉的开口分布及高度，有无主动脉扩张等，根据不同患者，选择不同瓣膜，制定不同手术策略。Meta分线显示BAV患者与TAV患者TAVR的相关终点无差异Heart,LungandCirculation,2015(24):649–6591.欧美心脏瓣膜病管理指南均推荐外科手术禁忌或高危、预期寿命超过12个月的症状性主动脉瓣重度狭窄患者作为TAVR的适应证。但是在这些研究中，BAV患者均被排除在外，指南也将BAV列为目前TAVR治疗的相对禁忌症。2.TAVR中国专家共识：指南推荐TAVR中国经验之——经颈动脉TAVR2015年11月，上海中山完成亚洲首例经颈动脉TAVR，之后又完成2例；浙二医院亦完成1例。4例手术结果满意。TAVR各种路入途径的缺点经股动脉途径：某些患者股动脉偏细或者有严重狭窄、扭曲无法送入18F-引导鞘管，而重度肥胖患者股动脉的穿刺、分离以及鞘管送入都存在困难。经心尖途径：伤口相对较大，且对心脏存在损伤，研究还显示经心尖途径生存率低于经股动脉途径。锁骨下动脉途径：虽然理论上较颈动脉途径安全，不用担心脑部并发症，但是有时候经锁骨下动脉走行扭曲，不利于输送鞘管送入；某些肥胖病人不易分离到锁骨下动脉。胸主动脉途径：伤口较大，出血较难处理，对升主动脉长度有要求，并且对既往有搭桥