少见的介入瓣膜手术肺动脉瓣

肺动脉瓣返流(右室流出道功能障碍)介入治疗适应症返流百分比>30%和持续多普勒监测右室流出道功能障碍峰速<3m/s右心室功能障碍活动能力下降

房性和/或室性心律失常Melody经导管瓣膜Melody经导管肺动脉瓣膜

重建和维持肺动脉瓣关闭完好

缓解管道狭窄的同时不造成新的返流T.Jones,TCT2008全球的经验BonhaufferP,TCT2008Melody:患者特征BonhaufferP,TCT2008血流动力学影响(n=121)Lurzetal,Circulation,2008,Apr15;117(15):1964-72

血流动力学影响(n=121)Lurzetal,Circulation,2008,Apr15;117(15):1964-72

血流动力学影响(n=121)Lurzetal,Circulation,2008,Apr15;117(15):1964-72

学习曲线Lurzetal,Circulation,2008,Apr15;117(15):1964-72

学习曲线Lurzetal,Circulation,2008,Apr15;117(15):1964-72

Melody®TPVUSIDEStudyT.Jones,TCT2008USFDAIDE研究–目前进展情况初始队列研究，30名患者/3个中心•前瞻性,非随机化•20071月

开始•20077月所有患者均纳入•20088月–向FDA递交申请继续在5个中心进行进一步的研究•FDA批准本研究纳入120名患者•所有患者随访5年患者目前情况•共76名患者•16个慈善机构/急诊患者T.Jones,TCT2008纳入标准年龄≥5岁体重≥30kg管道>16mm管道

功能障碍纳入标准NYHAII,III,IV平均右室流出道功能障碍压差≥35mmHg,或中重度肺动脉返流NYHAI平均右室流出道功能障碍≥40mmHg,或重度

肺动脉返流合并右室扩张或功能障碍*右心室扩张的定义是三尖瓣瓣环直径

≥2.0**右心室功能障碍的定义是

右室面积变化<40%首选适应症狭窄:仅满足压力差标准返流:仅满足肺动脉返流标准混合:满足压力差和肺动脉返流标准T.Jones,TCT2008患者特征T.Jones,TCT2008操作资料30名患者,29名成功放置支架操作时间

－182min(76-448)造影时间45min(9-87)入路股静脉–29颈内静脉–1大小最窄直径12.8(8-19)球囊大小28/30球囊最小直径16.8(14-20)T.Jones,TCT2008操作结果T.Jones,TCT2008血流动力学资料T.Jones,TCT20086个月随访T.Jones,TCT2008Edward-Sapien瓣膜

纳入标准体重>35kg管道>16mm重度

肺动脉返流>3+或>40%返流分数有症状(心肺活动测试)绝大多数患者进行随访Z.Hijazi,TCT2008Edward-Sapien瓣膜

患者Z.Hijazi,TCT2008Edward-Sapien瓣膜

最初结果Z.Hijazi,TCT2008总结LessCommonInterventionalValves

PulmonaryValve

SamirKapadia,MD,FACC

AssociateProfessorofMedicine

Director,InterventionalCardiologyFellowship

ClevelandClinic

Disclosures:NonePulmonaryRegurgitation(RVOTdysfunction)NeedforinterventioninRVOTdysfunctionfollowingcongenitalheartdiseaserepairisincreasingLongstandingpulmonaryregurgitationleadstodecreasedexercisetolerance,RVdysfunctionandarrhythmia(atrial/ventricular)EarliercorrectionofPRmaypreserveRVfunctionIndicationsforInterventionRegurgitationFraction>30%andRVOTpeakvelocityoncontinuousDopplerwave<3m/sRVdysfunctionReducedexercisecapacityDocumentedatrialand/orventriculararrhythmiasMelodyTrans-catheterValveMelodyTrans-catheterPulmonaryValve

Restoreandmaintainpulmonaryvalvecompetency Relieveconduitstenosiswithoutinducingregurgitation

T.Jones,TCT2008WorldWideExperienceBonhaufferP,TCT2008Melody:PatientCharacteristicsBonhaufferP,TCT2008HemodynamicEffects(n=121)Lurzetal,Circulation,2008,Apr15;117(15):1964-72

HemodynamicEffects(n=121)Lurzetal,Circulation,2008,Apr15;117(15):1964-72

HemodynamicEffects(n=121)Lurzetal,Circulation,2008,Apr15;117(15):1964-72

LearningCurveLurzetal,Circulation,2008,Apr15;117(15):1964-72

LearningCurveLurzetal,Circulation,2008,Apr15;117(15):1964-72

Melody®TPVUSIDEStudy

T.Jones,TCT2008USFDAIDEStudy–CurrentStatusInitialCohortof30patients/3Centers•Prospective,non-randomized•January2007–firstimplant•September2007–enrollmentcompleted•August2008–submissiontoFDAforHDEapprovalContinuedAccessat5Centers•120totalpatientsapprovedbyFDAforenrollment•Allpatientswillbefollowedfor5yearsPatientstoDate•76/120studypatients•16Compassionate/EmergencyUsepatients

T.Jones,TCT2008InclusionCriteriaAge≥5yearsWeight≥30kgConduit>16mmConduitdysfunctionStudyInclusionCriteriaNYHAII,III,IVMeanRVOTgradient≥35mmHg,orModerateorSeverePRNYHAIMeanRVOTgradient≥40mmHg,orSeverePRwithRVdilation*ordysfunction***RVdilatationdefinedasz-scorefortricuspidannulardiameter≥2.0**RVdysfunctiondefinedasRVfractionalareachange<40%PrimaryIndicationGroupsStenotic:MeetsgradientcriteriononlyRegurgitant:MeetsPRcriteriononlyMixed:Meetsbothgradient&PRCriteria

T.Jones,TCT2008PatientCharacteristics

T.Jones,TCT2008ProceduralDataN=30attempted,29stentedProceduretime182minutes(76-448)Fluoroscopytime45minutes(9-87)VascularapproachFemoralvein–29Jugularvein–1SizeNarrowestdiameter12.8(8-19)Balloonsizing28/30Balloonminimalwaist16.8(14-20)

T.Jones,TCT2008ProceduralResults93%proceduralsuccess1homograftrupture1hadpost-implanttrans-conduitgradientof37mmHg3subjects(10%)hadproceduralcomplications1SVTrequiringDCcardioversion1perforationofdistalPA(treatedwithcoilembolization)1homograftrupture(emergentconduitexchange)

T.Jones,TCT2008HemodynamicData

T.Jones,TCT2008SixMonthFollowUpFollow-upcompletedinallpatientsMajorityofpatientsshowedanimprovementofatleastoneNYHAclassMeanRVOTgradientsignificantlyreducedfrompre-implanttofollow-upPulmonaryvalvecompetencywasmaintainedoverthefollow-upperiodCTfollow-upshowsnoevidenceofpulmonaryemboli

T.Jones,TCT2008Edward-SapienValveExperience

InclusionCriteriaWeight>35kgConduit>16mmSeverePR>3+or>40%regurgitantfractionSubjectissymptomatic(CPexercisetesting)MustcomplywithF/U

Z.Hijazi,TCT2008Edward-SapienValveExperience

PatientPopulationAge:15-71yearsDX:2postRoss;5postTet;1postRastelliPreGradient30-75mmHgPI:severe7patientshadprestenting;oneha