人工生物瓣膜的應(yīng)用及策略課件

HANCOCK?II

第二代生物瓣技術(shù)人工生物瓣膜的應(yīng)用及策略人工生物瓣膜的應(yīng)用及策略人工生物瓣膜的應(yīng)用及策略Carpentier-Edwards

Perimount?Bioprostheses

Magnavalve PERIMOUNTvalve

(CEP)人工生物瓣膜的應(yīng)用及策略保存方法：在壓力下應(yīng)用戊二醛

，促進(jìn)膠原纖維之間的交聯(lián)膠原纖維交聯(lián)可避免膠原纖維斷裂膠原纖維斷裂最終可以導(dǎo)致鈣化形成，進(jìn)而導(dǎo)致瓣膜失效人工生物瓣膜的應(yīng)用及策略生理固定對(duì)Valsalva竇和瓣葉功能的作用瓣葉以生理的45°

連接瓣葉可以很好的開(kāi)到竇中生理壓力固定流出孔平面附著的天然角度Valsalva竇沒(méi)有保留

沒(méi)有空間使瓣葉活動(dòng)到Valsalva竇中去

潛在的血流受阻附著角度變平使得瓣葉尖部需要活動(dòng)的更遠(yuǎn)，并改變了瓣葉的應(yīng)力狀態(tài)流出孔平面附著角度變平影響血流動(dòng)力學(xué)和耐久性人工生物瓣膜的應(yīng)用及策略減輕生物機(jī)械性

失效新鮮瓣葉戊二醛固定方法的進(jìn)步低壓Hancock?IIIntact第二代高壓Hancock?MOHancock?

Std.第一代生理固定?Mosaic?Freestyle?第三代人工生物瓣膜的應(yīng)用及策略放射顯像：取出的豬生物瓣LentzDetal.InhibitionofMineralizationofGlutaraldehyde-FixedHancockBioprostheticHeartValves.In:CohnLH,GalucciV(ed)CardiacBioprostheses,Proceedingsofthe2ndInt’lSymp.YorkMedBooks,NY1982306-19T6處理后（左）

未處理（右）流出道面。在植入4個(gè)月后取出的Hancock瓣膜。標(biāo)準(zhǔn)瓣膜(right)，和T6處理后的(left).人工生物瓣膜的應(yīng)用及策略AminogroupAOA法至少?gòu)娜齻€(gè)方面減少鈣化:降低了鈣離子彌散到組織中的速度在戊二醛固定的組織上形成了性能良好且耐久性強(qiáng)的結(jié)合。（共價(jià)結(jié)合）可能可以洗脫一些脂質(zhì)來(lái)自天然產(chǎn)生帶油酸人工生物瓣膜的應(yīng)用及策略AOA-treatedNon-treatedDuarte;EmoryUniversity,Atlanta,GA放射顯像提示了鈣化組織的位置AOA處理的瓣膜及對(duì)照組的大體外觀Mosaic瓣羊研究:

植入5個(gè)月后取出：人工生物瓣膜的應(yīng)用及策略第一代支架HKI聚丙烯第二代支架HKII聚甲醛支架變薄圓形凸起側(cè)高降低2mmX線可探查的環(huán)及孔人工生物瓣膜的應(yīng)用及策略瓣環(huán)下縫合圈和瓣環(huán)下瓣架瓣環(huán)上縫合圈和瓣環(huán)下瓣架瓣環(huán)上縫合圈和瓣環(huán)上瓣架瓣環(huán)內(nèi)人工瓣真正的瓣環(huán)上(Supra-X?)Supra-X?真正的環(huán)上環(huán)外瓣人工生物瓣膜的應(yīng)用及策略SupraX:瓣孔面積瓣架在孔內(nèi)孔徑相當(dāng)于瓣架內(nèi)徑瓣環(huán)內(nèi)沒(méi)有任何阻礙中央孔和瓣環(huán)面積匹配需要全新的測(cè)瓣概念瓣環(huán)支架孔面積Supra-X瓣環(huán)上縫合環(huán)CEPHKII,Mosaic人工生物瓣膜的應(yīng)用及策略瓣膜開(kāi)閉更接近真實(shí)人體瓣膜拼合式生物瓣（牛心包瓣或豬瓣膜等）HancockII人工生物瓣膜的應(yīng)用及策略二尖瓣位 -> 安全、迅速、不掛線主動(dòng)脈瓣位全球?qū)＠鸆INCHTM旋轉(zhuǎn)收縮瓣角機(jī)制其他產(chǎn)品人工生物瓣膜的應(yīng)用及策略人工生物瓣膜的應(yīng)用及策略Hancock?II二尖瓣人工生物瓣膜的應(yīng)用及策略縫合圈與支架均置于環(huán)間:縫合圈置于環(huán)上支架置于環(huán)間:真正的環(huán)上瓣(Supra-X):縫合圈與支架均置于環(huán)上的St.Jude

瓣環(huán)外徑CEP支架外徑HancockII瓣內(nèi)徑人工生物瓣膜的應(yīng)用及策略測(cè)瓣:真正的環(huán)上瓣HKIIvs環(huán)內(nèi)瓣CEPHancock?II測(cè)瓣器底部=HancockII生物瓣的內(nèi)徑=病人瓣環(huán)內(nèi)徑凸起=代表瓣膜支架柱的大小和位置，有助于確定正確植入方位CEP的環(huán)內(nèi)瓣測(cè)瓣器HKII側(cè)高HKII外徑HKII內(nèi)徑瓣號(hào)大小CEP支架外徑測(cè)瓣器底部人工生物瓣膜的應(yīng)用及策略21mm19.1mm21mm19.1mm21mmHancockII內(nèi)徑20.5mm23mmHKII瓣號(hào)=支架外徑>HKII內(nèi)徑=病人瓣環(huán)內(nèi)徑23mmHancockIICEP瓣號(hào)=CEP支架外徑=病人瓣環(huán)內(nèi)徑21mmCEPCEP外徑21mm病人瓣環(huán)21mm人工生物瓣膜的應(yīng)用及策略FeatureHancock?IISJMBiocor?SJMEpic?第幾代？2nd1st2nd

抗鈣化處理T6(十二烷基硫酸鈉)無(wú)Linx?(95%酒精)固定技術(shù)低壓低壓低壓支架聚甲醛FlexFit?共聚物FlexFit?共聚物性能對(duì)比人工生物瓣膜的應(yīng)用及策略組成設(shè)計(jì)三個(gè)瓣葉都是無(wú)冠瓣瓣葉低壓固定戊二醛

<1mmHg接合處有牛心包保護(hù)減少瓣葉在織物上的磨損

Celcon支架

–比乙縮醛均聚物（HKII支架）的抗張強(qiáng)度小，柔軟性差無(wú)抗鈣化處理Biocor生物瓣人工生物瓣膜的應(yīng)用及策略連接處猶打結(jié)般，擋在流出道，跨瓣壓差升高薄弱環(huán)節(jié)，是血栓形成和鈣化的潛在發(fā)生位點(diǎn)Biocor主動(dòng)脈瓣人工生物瓣膜的應(yīng)用及策略EpicLinx處理–僅采用乙醇

–與Biocor相比，并沒(méi)有減少鈣化一項(xiàng)20周的利用小羊二尖瓣置換模型進(jìn)行的研究，用于研究(BiocorvsEpic)的安全性和有效性，以及銀的釋放速率和營(yíng)養(yǎng)不良性鈣化的程度……結(jié)果：20周的羊模型無(wú)法檢測(cè)出Epic和Biocor生物瓣之間鈣沉積的差別*無(wú)有效遠(yuǎn)期數(shù)據(jù)*Langankietal;JournalofHeartValveDisease:1998Nov;7(6):633-8.+=BiocorLinxEpic人工生物瓣膜的應(yīng)用及策略SJ說(shuō)他們的側(cè)瓣高只有11mm但是過(guò)低的側(cè)瓣高=更差的血流動(dòng)力學(xué)人工生物瓣膜的應(yīng)用及策略HancockII側(cè)高過(guò)低的瓣膜人工生物瓣膜的應(yīng)用及策略瓣號(hào)(mm)品牌21232527Biocor26212117HKII121211

813131212(mmHg)跨瓣壓差芬蘭心臟中心因?yàn)楦呖绨陦翰钔Ｖ故褂肂iocor轉(zhuǎn)用低跨瓣壓差的HancockIIMykenP等《St.JudeMedicalBiocor豬心瓣15年隨訪結(jié)果》“心臟瓣膜疾病雜志”2000年第9卷415-422頁(yè)高跨瓣壓差導(dǎo)致過(guò)早衰敗?。∪斯ど锇昴さ膽?yīng)用及策略Biocor與HancockII15年瓣膜結(jié)構(gòu)衰敗率比較Biocor-KiraliBiocor-MykenHKIIHKII1.MykenP,Bech-Hanssen,PhippsB,CaidahlK.FifteenYearsFollowUpwiththeSt.JudeMedicalBiocorPorcineBioprosthesis.JHeartValveDis2000;9:415-4222.Davidet.al;LaterresultsofheartvalvereplacementwithHancockIIBioprosthesis;TheJournalofThoracicandCardiovascularSurgery:Vol121,Number2Pg268-2783.Kiralietal;FifteenyearclinicalexperiencewiththeBiocorPorcineBioprosthesisintheMitralposition;AnnThoracicSurgery2001;71:811-815二尖瓣主動(dòng)脈瓣人工生物瓣膜的應(yīng)用及策略Epic是什么?

SJMEpic沒(méi)有長(zhǎng)期或短期的臨床研究證據(jù)！Linx?抗鈣化處理可能使血流動(dòng)力學(xué)表現(xiàn)進(jìn)一步降低，因?yàn)榫凭梢灾饾u使組織干燥和變硬。(Linx?使用的是95%的酒精）

研究未能證實(shí)經(jīng)過(guò)Linx?處理的瓣膜比沒(méi)有處理過(guò)的Biocor瓣膜具有任何優(yōu)勢(shì)。（同時(shí)也沒(méi)有人類(lèi)研究證據(jù)）Epic只不過(guò)是額外增加了Linx?處理的Biocor瓣人工生物瓣膜的應(yīng)用及策略ACC

AHA指南對(duì)生物瓣使用的建議：AVR:Patients<65:WithdiscussionwithsurgeonaboutstrongriskofreoperationversustheriskofanticoagulationWomenofchildbearingageMVR:Patients<65who:AreinsinusrhythmandWithdiscussionwithsurgeonaboutstrongriskofreoperationversustheriskofanticoagulationAnyage:Patientswhowillnotorcannottakewafarinanticoagulation人工生物瓣膜的應(yīng)用及策略病人年紀(jì)越大，耐久性越好Patientages人工生物瓣膜的應(yīng)用及策略不同病人年齡的換瓣選擇MechanicalTissuePatientAgeAveragepatientage人工生物瓣膜的應(yīng)用及策略人工生物瓣膜的應(yīng)用及策略No.ofPt.228(MVR:54%)MeanAge(range)27+/-7.6(11-40)FollowupLosttofollowup10.5years3%ActuarialFreedomfromStructuralValveDeterioration(SVD)85.2±4.8%ActuarialFreedomfromtotalTE97.6±1.1%ActuarialFreedomfromEndocarditis96.7±1.4%ActuarialFreedomfromReoperation72±5.9%ActuarialSurvivalat10.5years91±2.2%Z.AlHalees,BGometza,AAlSanel,CMDuranBehavioroftheHancockIIBioprosthesisinYoungPopulation.WorldSymposiumonHeartValveDisease,1999London.FromtheKingFaisalSpecialistHospitalandResearchCentre,Riyadh,SaudiArabiaandInternationalHeartInstituteofMontanafoundation,Missoula,Montana,USAHANCOCK?IIPerformanceinPatientsAges11-40人工生物瓣膜的應(yīng)用及策略BenefitsofPhysiologicFixation?PhysiologicFixationPressureFixationHingesitePhysiologicFixation?人工生物瓣膜的應(yīng)用及策略Supra-X?Positioning

Supra-X?positioningensurestheMosaicbioprosthesisisseatedsupra-annularlywhilealigningtheinternaldiameterofthevalvewiththepatient’sannulusNointra-annularcomponentIncreasesareaavailabletoflow

人工生物瓣膜的應(yīng)用及策略Intra-annular

sewingringwith

intra-annularvalveSupra-annular

sewingringwith

intra-annularvalveTrueSupra-annular

(Supra-X?):

Supra-annularsewingringwithsupra-annularvalveIntra-annularvalvesSupra-annularvalveSupra-X?Positioning人工生物瓣膜的應(yīng)用及策略經(jīng)導(dǎo)管肺動(dòng)脈瓣膜PhilippeBonhofer-90年代后期可用-首次在人類(lèi)應(yīng)用可以為嬰兒贏得時(shí)間，可以延后接受外科手術(shù)的時(shí)間上腔靜脈路線從10月1日起已經(jīng)超過(guò)800例病人人工生物瓣膜的應(yīng)用及策略經(jīng)導(dǎo)管主動(dòng)脈瓣膜置換CoreValve…….

可能還有更多!Cribier,Edwards人工生物瓣膜的應(yīng)用及策略人工生物瓣膜的應(yīng)用及策略人工生物瓣膜的應(yīng)用及策略ActuarialFreedomFromSVDat12years

Mosaic?1CEP2Patients(n)255310PatientAge(mean)6764.212-YearActuarialSurival64.1±5.6%34±3%FreedomFromExplantduetoSVD90.2±4.1%82±4%REFERENCES1Riess,FCetal.,HemodynamicPerformanceandClinicalFollow-upoftheMedtronicMosaicBioprosthesisupto12Years.ABSTRACT,presentedattheSHVD,NewYork,NY,2007.BanburyMKetal.,Long-TermResultsoftheCarpentier-EdwardsPericardialAorticValve:A12-YearFollow-Up.AnnThoracSurg1998;66:S73–6.BanburyMKetal.,AgeandValveSizeEffectontheLong-TermDurabilityoftheCarpentier-EdwardsAorticPericardialBioprosthesis.AnnThoracSurg2001;72:753-7.ExplantsduetoSVDat10years

Mosaic?1CEP2Patients(n)797310PatientAge(mean±sd)69±965±12NumberofReoperationsduetoSVD1721PercentofPatientswithReoperationsduetoSVD2%7%人工生物瓣膜的應(yīng)用及策略ConfidentialMitralRegurgitationPossibleReasonsIthasaholeinitUnequalleafletelasticityLowstentpostsCausesleafletcoaptationzonetobeverysmallTriangleofleak人工生物瓣膜的應(yīng)用及策略CEPValve人工生物瓣膜的應(yīng)用及策略SizingandImplantationSizingImplantInflowViewHancockIICEPStentIDStentIDStentODAnnulusStentOrificeArea人工生物瓣膜的應(yīng)用及策略人工生物瓣膜的應(yīng)用及策略Notallsizersarethesame

25mm28mmHancockIImitralvalvesizer25mmCEPmitralvalvesizer25mm人工生物瓣膜的應(yīng)用及策略Notallsizersarethesame

Upsize人工生物瓣膜的應(yīng)用及策略PlasticismoreFlexiblethanMetalHancockIIvalvePlastic(acetalhomopolymer)stent.LowmemoryandflexibleCEPMetalstentMetalhasmemoryandcanbreakPlasticMetalVSCEPIFU:Duetotherelativeflexibilityoftheframe,caremustbeexercisedtopreventfoldingordeformationofthestent,thatmightleadto

regurgitation,alteredhemodynamics,and/orleafletdisruptionrenderingthevalveincompetent.人工生物瓣膜的應(yīng)用及策略EaseofImplantAorticPosition:CINCHTM

HolderPro23mmCarpentier?EdwardsPerimount?23mmHII?withtheCINCHTM人工生物瓣膜的應(yīng)用及策略EaseofImplant:CINCHTM

InAortaPro人工生物瓣膜的應(yīng)用及策略HemodynamicComparisonEOA人工生物瓣膜的應(yīng)用及策略HemodynamicComparison

MeanGradientMosaic人工生物瓣膜的應(yīng)用及策略HemodynamicComparison

MeanGradientCEP人工生物瓣膜的應(yīng)用及策略WeightedaverageofMeanGradientMOSAICCEP#ofPatientsn=2804MeanGradient#ofPatientsn=998MeanGradient19mm718.512920.321mm55814.639917.523mm115413.431913.625mm75211.712512.127mm27410.22610.929mm598.90Nodata人工生物瓣膜的應(yīng)用及策略PORCINEvsPORCINE?

Whatmakesadifference?

人工生物瓣膜的應(yīng)用及策略SJMBiocor?StentedTissueValveBiocorisaregisteredtrademarkofSt.JudeMedicalInc.

Biocor?Epic?人工生物瓣膜的應(yīng)用及策略History1978BiocorporcinevalvedevelopedbyDr.MarioVrandecicinBrazil.1982Biocorvalvereleased.1996September:SJMacquiresBiocortissuevalvecompany.1998BiocorreceivesCEMark.

2003USclinicalstudybeginsontheSJMEpic?withLinx?AC2003EuropeanlaunchoftheEpicSupra?2004FirstNorthAmericanimplantofitsSJMEpic?Supravalve.

2005August8th

BiocorapprovedforsaleinUnitedStates.人工生物瓣膜的應(yīng)用及策略ValveFeatureComparisonFeatureMosaic?MosaicULTRA?Hancock?IIHancockIIULTRA?SJMBiocor?SJMEpic?Generation3rd

2nd1st2nd

Anti-mineralizationTreatmentAOA?T6(Sodiumdodecylsulfate)NONELinx?(95%ethanol)FixationPhysiologicFixation?Low/HighPressureLowPressureLowPressureStentAcetalHomopolymerAcetalHomopolymerFlexFit?CopolymerFlexFit?CopolymerSewingcuffPolyesterPolyesterPolyesterSiliconeinsertPolyesterSiliconeinsert人工生物瓣膜的應(yīng)用及策略CompositedesignThreenon-coronarycuspsLowpressurefixationGlutaraldehyde<1mmHgPericardialshieldontheoutflowedge

reduceleafletabrasionagainstfabricCelconstent

–lowertensilestrengthandlessflexiblethanacetalhomopolymer(HKIIstent).Noanti-calcificationtreatmentBiocorbioprostheses人工生物瓣膜的應(yīng)用及策略EpicLinxtreatment–justethanol–noreductionincalcificationvsBiocorA20-weekjuvenilesheepmitralvalveimplantmodelwasusedtodeterminesafetyandefficacyofthedevice(BiocorvsEpic),aswellastherateofsilverreleaseanddegreeofdystrophiccalcification…Results:the20-weeksheepmodelunabletodetectdifferencesincalciumaccumulationbetweentheEpicandtheBiocor*Nolong-termdataavailable*Langankietal;JournalofHeartValveDisease:1998Nov;7(6):633-8.+=BiocorLinxEpic人工生物瓣膜的應(yīng)用及策略Biocor–Howisitproduced?人工生物瓣膜的應(yīng)用及策略Hemodynamics

Notallporcinevalvesarethesame-Biocor–

LowerProfile,WorseHemodynamics人工生物瓣膜的應(yīng)用及策略FeaturesProfile:LeafletsAreSTUFFEDintostentsthataretoosmallHigherleafletstressesLeafletprotrusion 人工生物瓣膜的應(yīng)用及策略Pericardialshieldobstructingflowarea.

Shieldinhibitsleafletsfromopeningfully.

BiocorAorticValveStressfoldsareevidentradiatingfromthebaseofthecommisuresaswellascoaptationmis-alignment.

人工生物瓣膜的應(yīng)用及策略BiocorHKII,Mosaic人工生物瓣膜的應(yīng)用及策略人工生物瓣膜的應(yīng)用及策略AcceptableHemodynamics?MykénPSetal.,LONG-TERMDOPPLERECHOCARDIOGRAPHICRESULTSOFAORTICORMITRALVALVEREPLACEMENTWITHBIOCORPORCINEBIOPROSTHESIS.JThoracCardiovascSurg1998;116:599-608.Wouldgradientsofupto60mmHgbeacceptablewithaMosaicorHancockII?

人工生物瓣膜的應(yīng)用及策略DurabilityNotallporcinevalvesarethesame-Anotherwaytolookatthedata人工生物瓣膜的應(yīng)用及策略ComparisonofSVDbetween

BiocorandHancockIIat15yrsBiocor-KiraliBiocor-MykenHKIIHKII1.MykenP,Bech-Hanssen,PhippsB,CaidahlK.FifteenYearsFollowUpwiththeSt.JudeMedicalBiocorPorcineBioprosthesis.JHeartValveDis2000;9:415-4222.Davidet.al;LaterresultsofheartvalvereplacementwithHancockIIBioprosthesis;TheJournalofThoracicandCardiovascularSurgery:Vol121,Number2Pg268-2783.Kiralietal;FifteenyearclinicalexperiencewiththeBiocorPorcineBioprosthesisintheMitralposition;AnnThoracicSurgery2001;71:811-815人工生物瓣膜的應(yīng)用及策略VSClinicalComparison人工生物瓣膜的應(yīng)用及策略AorticBiocorHKIINo.ofPatients4551010MeanAges72±967±11NYHAclassIIIorIV45%77%Follow-upmeanyr7.4±4.98.2Follow-upcompetency99.6%99.9%ComparisonofSVDbetween

BiocorandHancockIIat20yrsAorticBiocorHKIISurvival10yr45%61%20yr9%19%FreedomfromSVD15yr88%93%20yr70%80%人工生物瓣膜的應(yīng)用及策略ImplantabilityNotallporcinevalvesarethesame-TheCinchMakesADifference人工生物瓣膜的應(yīng)用及策略TheBiocorplasticstentislessflexiblethantheHKIIstent.TheBiocorstentpostareunabletodeflectaswellastheHKIIstentpost.TheBiocorhasabulkyholderwhichmakesitdifficultforthesurgeontovisualizeandtosecuretheknotsduringtheprocedureBiocorHancockII人工生物瓣膜的應(yīng)用及策略 Theory:

ReducesglutaraldehydetoxicityRemovescholesterolandlipidsReducesuptakeoflipidsfromthepatientintotheprosthesisTesting:Connolly,LevyRJetal.JHeartValveDis2004;13(3):487-93.Vyavahare,LevyRJetal.JBiomedMaterRes1998

40;577–585.Flameng,etal.AnnThoracSurg2001;71:S401-5.Langanki,etal.JHeartValveDis1998;7:633-638.

Shoen,LevyRJetal.AnnThoracSurg2005;79:1072–80).Linx?Technology人工生物瓣膜的應(yīng)用及策略WhatweknowaboutLinx?TheLinx?anticalcificationtreatmentisasimple95%ethanoltreatment.TheLinx?treatmenthasbeendevelopedbyDr.RobertLevyattheUniversityofMichiganandislicensedbySJM.21-dayratsubdermaltestswereperformed(Nohumanstudies!)20-dayjuvenilesheepstudiesshowednodifferencethanuntreatedBiocorsamples.Studiesfoundabnormallyhighamountsofcuspalhematomas.人工生物瓣膜的應(yīng)用及策略ProofSource?人工生物瓣膜的應(yīng)用及策略Vyavahare2000Paper“Ourinitialstudiesexploredethanolpretreatment,butonlyafterglutaraldehydefixation.Wealsodidnotexaminequestionsofstorageinglutaraldehydesolutionafterethanolpretreament.

“Inconclusion,glutaraldehydestoragefollowingethanolpretreatmentofglutaraldehyde-fixedbioprostheticheartvalvesnegatesinhibitionofcalcification,andwouldappeartobecontraindicatedinthefabricationofsuchvalvesforclinicaluse.”Vyavahare,etal.Preventionofglutaraldehyde-fixedbioprostheticheartvalvecalcificationbyalcoholpretreatment:furthermechanisticstudies.JHeartValDis

2000:9(4);561-6.人工生物瓣膜的應(yīng)用及策略WheredoesthatleaveEpic?Thereisnolongorshort-termclinicaldataavailableontheSJMEpic!Linx?anticalcificationtreatmentmightfurtherreducehemodynamicperformancesincealcoholgenerallydriesandstiffensthetissue.(Linx?is95%ethanol).StudieshavenotbeenabletoprovethatvalvestreatedwithLinx?performedanybetterthannon-treatedBiocorvalves(Noranyhumanstudies).

EpicissimplytheBiocorvalvewiththeadditionofLinx?人工生物瓣膜的應(yīng)用及策略SJM說(shuō)生物瓣側(cè)瓣越低越好，真是這樣嗎？生物瓣Newsletter人工生物瓣膜的應(yīng)用及策略?xún)煞N不同的豬主動(dòng)脈瓣完整豬主動(dòng)脈瓣瓣葉組合瓣人工生物瓣膜的應(yīng)用及策略完整的豬主動(dòng)脈瓣和人主動(dòng)脈瓣膜結(jié)構(gòu)對(duì)比人工生物瓣膜的應(yīng)用及策略DataSource:FDAApprovedInstructionsforUse.Valve19mm21mm23mm25mmHancockII(n=)NA12.9±4.2(9)13.2±4.6(47)11.3±4.4(50)Biocor&Supra(n=)NA18.8±6(40)17.3±9(97)15.2±5(61)Epic&Supra(n=)NA19.1±8(49)13.9±6(120)12.1±5(121)主動(dòng)脈血流動(dòng)力學(xué)FDA審批IFU數(shù)據(jù)：術(shù)后一年平均跨瓣壓差比較人工生物瓣膜的應(yīng)用及策略側(cè)瓣越低，瓣葉張力越大人工生物瓣膜的應(yīng)用及策略AorticBiocorHKIINo.ofPatients4551010MeanAges72±967±11NYHAclassIIIorIV45%77%Follow-upmeanyr7.4±4.98.2Follow-upcompetency99.6%99.9%20年生存率和耐久性的比較AorticBiocorHKIISurvival10yr45%61%20yr9%19%FreedomfromSVD15yr88%93%20yr70%80%人工生物瓣膜的應(yīng)用及策略人工生物瓣膜的應(yīng)用及策略86總結(jié)HKII采用豬的完整主動(dòng)脈瓣，解剖更加接近人體瓣膜結(jié)構(gòu)，瓣葉運(yùn)動(dòng)更符合生理情況Biocor降低了側(cè)瓣高度，導(dǎo)致瓣葉無(wú)法完全打開(kāi)，犧牲了血液動(dòng)力學(xué)生物瓣側(cè)瓣越低，瓣葉承受的張力越大，耐久性下降。而耐久性是生物瓣最重要的考慮因素美敦力的CINCH技術(shù)，能有效地避免二尖瓣植入時(shí)造成的心肌損傷。只要植入角度符合要求，左室流出道受阻極少發(fā)生。競(jìng)爭(zhēng)對(duì)手臨床實(shí)驗(yàn)比較人工生物瓣膜的應(yīng)用及策略FreedomFromSVD比較人工生物瓣膜的應(yīng)用及策略耐久性總結(jié)：60歲及以上患者FFSVD

85%60歲及以上患者AVR

FFSVD88%65歲及以上患者AVR

FFSVD97%指南建議年齡生物瓣患者首選！人工生物瓣膜的應(yīng)用及策略患者生存率生存率為什么重要？一切數(shù)據(jù)結(jié)果的基礎(chǔ)！人工生物瓣膜的應(yīng)用及策略免予結(jié)構(gòu)性衰敗率FFSVD60-70歲患者植入20年總體FFSVD

85%主動(dòng)脈FFSVD

88%60-70歲患者植入20年總體FFRSVD

90%主動(dòng)脈FFRSVD

92%人工生物瓣膜的應(yīng)用及策略FeatureHancock?IIＭosaicSJMBiocor?SJMEpic?EdwardsSAV第幾代？2nd3rd1st2nd

2nd

抗鈣化處理T6(Sodiumdodecylsulfate)ＡＯＡ無(wú)Linx?(95%酒精)Xenologix?固定技術(shù)低壓/微壓生理壓力低壓低壓低壓支架AcetalHomopolymerAcetalHomopolymerFlexFit?CopolymerFlexFit?CopolymerAlgiloy?合金支架瓣膜的分類(lèi)人工生物瓣膜的應(yīng)用及策略HKII和Perimount瓣葉重疊區(qū)域?qū)Ρ菻KIIPerimountDeepercoaptationShallowcoaptation人工生物瓣膜的應(yīng)用及策略MitralFFESVDMosaic182%HKII273.3%Perimount3,459%MedtronicMosaicAorticandMitralBioprosthesis:FifteenYearClinicalCompendium.?Medtronic,Inc.2012.CarloValfre`etal,ThefateofHancockIIporcinevalverecipients25yearsafterimplant.EuropeanJournalofCardio-thoracicSurgery38(2010)141—146BanburyMK.etal.,AgeandValveSizeEffectontheLong-TermDurabilityoftheCarpentier-EdwardsAorticpericardialBioprosthesis.AnnThoracSurg2001;72-753-7.Carpentier-EdwardsPERIMOUNTMitralPericardialBioprosthesisCommuniqué,Model6900,?2003EdwardsLifesciencesLLC.Mosaic是二尖瓣耐久性最好的生物瓣人工生物瓣膜的應(yīng)用及策略生物瓣衰敗原因物理性因素：血流沖擊撕裂等壓力組織原因瓣膜結(jié)構(gòu)衰敗化學(xué)性因素：固定劑鈣化SchoenF,LevyR.TissueHeartValves:CurrentChallengesandFutureResearchPerspectives.JBiomedMaterRes,47,439-465,1999人工生物瓣膜的應(yīng)用及策略如何對(duì)抗兩種瓣膜失效原因？??改進(jìn)瓣架設(shè)計(jì)(生物機(jī)械性)??改進(jìn)戊二醛處理和壓力固定技術(shù)(生物機(jī)械性）??使用抗鈣化劑(生物化學(xué)性)人工生物瓣膜的應(yīng)用及策略CINCHII有效的保護(hù)心室縱向環(huán)人工生物瓣膜的應(yīng)用及策略PERIMOUNTTHEONMODEL6900PTFXMAGNAMITRALEASEMODEL7300TFXThermaFixprocess*BioengineeredFlexibleCoCralloystentPericardialleafletsThermaFixprocess*BioengineeredFlexibleCoCralloystentPericardialleafletsSupra-annulardesignLowestprofile?EaseofimplantEdwardsMitral人工生物瓣膜的應(yīng)用及策略Edwards宣傳賣(mài)點(diǎn)經(jīng)過(guò)大量臨床數(shù)據(jù)驗(yàn)證的血液動(dòng)力學(xué)EOA&平均跨瓣壓差為耐久性而設(shè)計(jì)獨(dú)特的ThermaFix工藝提高了瓣膜的長(zhǎng)期性能安全易于植入Tricentrix傳送系統(tǒng)人工生物瓣膜的應(yīng)用及策略St.JudeMedicalBiocor?&Epic?

StentedTissueValves人工生物瓣膜的應(yīng)用及策略Biocor特點(diǎn)三片獨(dú)立瓣膜（無(wú)冠瓣）組合瓣FlexFit?System人工生物瓣膜的應(yīng)用及策略LinxAC

去鈣化功能人工生物瓣膜的應(yīng)用及策略瓣架:由于支架過(guò)低，留給瓣葉的空間過(guò)于狹小瓣葉承受更高壓力瓣葉更突出，無(wú)法保持自然形態(tài)

低瓣架設(shè)計(jì)與血流動(dòng)力學(xué)人工生物瓣膜的應(yīng)用及策略St.JudeBiocor?

帶支架生物瓣BiocorisaregisteredtrademarkofSt.JudeMedicalInc.

Biocor?Epic?人工生物瓣膜的應(yīng)用及策略復(fù)合瓣葉設(shè)計(jì)由三片獨(dú)立裁剪的無(wú)差異瓣葉組成低壓固定技術(shù)固定壓力小于1mmHgGlutaraldehyde<1mmHg流出道瓣腳邊緣心包保護(hù)

減少瓣葉與紡織物之間的摩擦Celcon材料支架

–低強(qiáng)度，低彈性支架（與HKII支架相比較）無(wú)抗鈣化處理Biocor人工生物瓣膜人工生物瓣膜的應(yīng)用及策略Epic人工生物瓣膜Linx抗鈣化試劑主要成分–無(wú)水酒精

–沒(méi)有帶來(lái)比Biocor更好的抗鈣化效果一項(xiàng)針對(duì)Biocor和EPIC抗鈣化效果試驗(yàn)的結(jié)果顯示，在小羊體內(nèi)植入Biocor和EPIC二尖瓣，20周后，EPIC在鈣離子沉積效果上，與Biocor并無(wú)差異！缺乏長(zhǎng)期臨床數(shù)據(jù)支持*Langankietal;JournalofHeartValveDisease:1998Nov;7(6):633-8.+=BiocorLinxEpic人工生物瓣膜的應(yīng)用及策略抗鈣化能力:6周之后

5/5Magna

發(fā)生鈣化

中心留有縫隙1/5Mosaic

發(fā)生鈣化

人工生物瓣膜的應(yīng)用及策略abcdefgOpeningandClosingkinematics:Magna(top)andMosaic(bottom)Calcium人工生物瓣膜的應(yīng)用及策略擴(kuò)大1個(gè)瓣號(hào)擴(kuò)大2個(gè)瓣號(hào)正常瓣號(hào)牛瓣豬瓣瓣葉根部無(wú)法移動(dòng)Increaseingradientobservedwheninflowofvalveisobstructed人工生物瓣膜的應(yīng)用及策略新測(cè)瓣器使用步驟第一步:使用測(cè)瓣器桶端測(cè)量瓣膜大小*Ifthepotentialexistsfor(a)valveprosthesisinterferencewithcoronaryostia,(b)tissueobstructiontovalveprosthesisinflow,or(c)deformationofthevalveprosthesisstent,considerreorientationofthevalve,selectingasmallervalvesize,oraddressingtheobstructionorinterferencesurgically.第二步：用模擬端觀察植入后瓣環(huán)上下情況確保瓣膜不會(huì)阻擋主動(dòng)脈血流*Example:23mm檢查瓣膜流入是否受阻*此例顯示，25mm瓣膜對(duì)23mm瓣膜的比較新Mosaic測(cè)瓣器ReplicaEndBarrelEnd23mmDONOTCOPY–NOTFORDISTRIBUTION第三步(可選):使用大一號(hào)瓣膜測(cè)試Example:25mm人工生物瓣膜的應(yīng)用及策略Theclosingproblem(Strokevolume80ml/6weeks)–4l/40bpm(highstrokevolumeof80ml)MOSAICULTRAMAGNA人工生物瓣膜的應(yīng)用及策略CEPMosaicCEPMosaicCEPMosaic70BPM5l/minnormal150BPM8l/minexercise130BPM2.5l/minLowCOOpeningTime(msec)Freshvalves48±1027±638±1127±554±1230±8ClosureTime(msec)Freshvalves111±1274±1068±1148±886±1553±9OpeningTime(6weeks)55±1228±10ClosureTime(6weeks135±1177±9人工生物瓣膜的應(yīng)用及策略NodesofArantiusNaturalandporcinevalveshavethenodesofArantiuswherethreecuspcoaps,pericardialvalvesdoNOThavethis.Pericardialvalvehaveopeninginthecenterofleafletstocompensatetheleafletabrasion.NaturalvalvePorcinevalvePericardialvalve人工生物瓣膜的應(yīng)用及策略術(shù)后1-5年返流對(duì)比（Mitral）人工生物瓣膜的應(yīng)用及策略RegurgitationinCEPvalves:Banburyetal.AnnThoracSurg2002;73:1460-5After12years:50%ofthesepericardialvalvesshowednoneortrace(trivial)regurgitation30%showedmildregurgitationandtheremaining20%moderatetosevere.人工生物瓣膜的應(yīng)用及策略 AVRMVR

5yrs 11yrs 5yrs 10yrs (n=161) (n=11) (n=25) (n=9) % % % % none 87.0 63.6 96.0 100 trivial 8.1 27.3 - - mild 4.3 9.1 4.0 - moderate 0.6 - - - severe - - - -RiessFC,BaderR,CramerE,HansenL,WahlG,WinkelS,BleeseNAlbertinenHeartCenter,HamburgMosaicData90,9%noneortrivialregurgitationforAortic人工生物瓣膜的應(yīng)用及策略血流動(dòng)力學(xué)對(duì)比總結(jié)：Mosaic和HKII接近生理結(jié)構(gòu)，牛瓣設(shè)計(jì)缺陷存在返流危險(xiǎn)Mosaic/HKII開(kāi)合速度優(yōu)于牛瓣，更符合生理?xiàng)l件下瓣膜特點(diǎn)開(kāi)口面積不是血流動(dòng)力學(xué)唯一決定因素！返流同樣增加心肌能量損耗Mosaic/HKII和牛瓣在瓣號(hào)選擇上存在錯(cuò)位。相同條件下，Mosaic/HKII血流動(dòng)力更有優(yōu)勢(shì)無(wú)論從哪個(gè)角度比較，Mosaic都擁有更低的返流風(fēng)險(xiǎn)，血液動(dòng)力學(xué)更穩(wěn)定。人工生物瓣膜的應(yīng)用及策略AorticFFESVDMitralFFESVDMosaic189%82%Perimount3,477%59%15-YearFreedomFromSVDComparisonMedtronicMosaicAorticandMitralBioprosthesis:FifteenYearClinicalCompendium.?Medtronic,Inc.2012.DavidTE.etal.,LateresultsofheartvalvereplacementwiththeHancockIIBioprosthesis.JThoracCardiovascSurg2001;121:268-78.BanburyMK.etal.,AgeandValveSizeEffectontheLong-TermDurabilityoftheCarpentier-EdwardsAorticpericardialBioprosthesis.AnnThoracSurg2001;72-753-7.Carpentier-EdwardsPERIMOUNTMitralPericardialBioprosthesisCommuniqué,Model6900,?2003EdwardsLifesciencesLLC.總體耐久性對(duì)比人工生物瓣膜的應(yīng)用及策略易植入性-

Cinch技術(shù)HancockII旋轉(zhuǎn)手柄，瓣腳向內(nèi)收縮CEP瓣架缺少?gòu)椥裕昴_無(wú)法完全收縮，會(huì)增加縫合難度，增加返流風(fēng)險(xiǎn)人工生物瓣膜的應(yīng)用及策略聚酯材料比金屬更具彈性HancockII