肺動脈瓣返流(右室流出道功能障礙)介入治療適應(yīng)癥返流百分比>30%和持續(xù)多普勒監(jiān)測右室流出道功能障礙峰速<3m/s右心室功能障礙活動能力下降

房性和/或室性心律失常Melody經(jīng)導(dǎo)管瓣膜Melody經(jīng)導(dǎo)管肺動脈瓣膜

重建和維持肺動脈瓣關(guān)閉完好

緩解管道狹窄的同時不造成新的返流T.Jones,TCT2008全球的經(jīng)驗BonhaufferP,TCT2008Melody:患者特征BonhaufferP,TCT2008血流動力學(xué)影響(n=121)Lurzetal,Circulation,2008,Apr15;117(15):1964-72

血流動力學(xué)影響(n=121)Lurzetal,Circulation,2008,Apr15;117(15):1964-72

血流動力學(xué)影響(n=121)Lurzetal,Circulation,2008,Apr15;117(15):1964-72

學(xué)習(xí)曲線Lurzetal,Circulation,2008,Apr15;117(15):1964-72

學(xué)習(xí)曲線Lurzetal,Circulation,2008,Apr15;117(15):1964-72

Melody?TPVUSIDEStudyT.Jones,TCT2008USFDAIDE研究–目前進(jìn)展情況初始隊列研究，30名患者/3個中心?前瞻性,非隨機化?20071月

開始?20077月所有患者均納入?20088月–向FDA遞交申請繼續(xù)在5個中心進(jìn)行進(jìn)一步的研究?FDA批準(zhǔn)本研究納入120名患者?所有患者隨訪5年患者目前情況?共76名患者?16個慈善機構(gòu)/急診患者T.Jones,TCT2008納入標(biāo)準(zhǔn)年齡≥5歲體重≥30kg管道>16mm管道

功能障礙納入標(biāo)準(zhǔn)NYHAII,III,IV平均右室流出道功能障礙壓差≥35mmHg,或中重度肺動脈返流NYHAI平均右室流出道功能障礙≥40mmHg,或重度

肺動脈返流合并右室擴張或功能障礙*右心室擴張的定義是三尖瓣瓣環(huán)直徑

≥2.0**右心室功能障礙的定義是

右室面積變化<40%首選適應(yīng)癥狹窄:僅滿足壓力差標(biāo)準(zhǔn)返流:僅滿足肺動脈返流標(biāo)準(zhǔn)混合:滿足壓力差和肺動脈返流標(biāo)準(zhǔn)T.Jones,TCT2008患者特征T.Jones,TCT2008操作資料30名患者,29名成功放置支架操作時間

－182min(76-448)造影時間45min(9-87)入路股靜脈–29頸內(nèi)靜脈–1大小最窄直徑12.8(8-19)球囊大小28/30球囊最小直徑16.8(14-20)T.Jones,TCT2008操作結(jié)果T.Jones,TCT2008血流動力學(xué)資料T.Jones,TCT20086個月隨訪T.Jones,TCT2008Edward-Sapien瓣膜

納入標(biāo)準(zhǔn)體重>35kg管道>16mm重度

肺動脈返流>3+或>40%返流分?jǐn)?shù)有癥狀(心肺活動測試)絕大多數(shù)患者進(jìn)行隨訪Z.Hijazi,TCT2008Edward-Sapien瓣膜

患者Z.Hijazi,TCT2008Edward-Sapien瓣膜

最初結(jié)果Z.Hijazi,TCT2008總結(jié)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