心臟瓣膜疾病介入治療現(xiàn)狀及進展

心臟瓣膜介入技術(shù)現(xiàn)狀與展望復(fù)旦大學(xué)附屬中山醫(yī)院心外科魏來TAVRTranscatheterAorticValveReplacement臨床試驗ROUTE注冊研究:經(jīng)主動脈2011CoreValveUSPivotaltrial外科中危病人:USPARTNER2SURTAVIPARTNERI:5年結(jié)果申辦者:EdwardsLifesciencesEdwardsSAPIENvs.外科換瓣vs.藥物治療和/或球囊擴張

PARTENERI–5年結(jié)果

TAVRVS.SAVRPARTENERI–5年結(jié)果5-yearoutcomesoftranscatheteraorticvalvereplacementorsurgicalaorticvalvereplacementforhighsurgicalriskpatientswithaorticstenosis(PARTNER1):arandomisedcontrolledtrial.MackMJetal.Lancet.(2015)結(jié)論：全因死亡率無差異;心血管死亡率無差異;中位生存時間無差異;神經(jīng)系統(tǒng)并發(fā)癥無差異;PARTENERI–5年結(jié)果

TAVRVS.SAVRPARTENERI–5年結(jié)果

TAVRVS.

藥物治療5-yearoutcomesoftranscatheteraorticvalvereplacementcomparedwithstandardtreatmentforpatientswithinoperableaorticstenosis(PARTNER1):arandomisedcontrolledtrial.KapadiaSRetal.Lancet.(2015)結(jié)論:對于無法耐受外科手術(shù)的病例，TAVR較藥物治療能使病人更多獲益.PARTNERII申辦者:EdwardsLifesciencesEdwardsSAPIENXT&

SAPIEN

3 PARTNERII初步結(jié)果30天死亡率:

2.2%30天卒中率:

1.5%30天心血管死亡率:

1.4%

30天致殘卒中率:

0.9%商業(yè)化的器械CE:EdwardsSAPIENXTTM

MedtronicCoreValve?JenaValveTM

AcurateTATM

USEdwardsSAPIENXTTM

EdwardsSAPIEN3TMMedtronicCoreValve?EdwardsSAPIENMedtronicCoreValveMedtronicEngagerJenaValveSymetisACURATEValve-in-ValveTechnique尚缺乏大樣本對照研究TranscatheterValve-in-ValveImplantation:ASystematicReviewofLiterature.JwalantRaval,etal.Heart,LungandCirculation(2014).GlobalValve-in-ValveRegistry2012

n=202最大和平均跨瓣壓差：28.41±4.1/15.9±8.6mmHg≤+1主動脈瓣反流：95%30-day全因死亡率:8.4%NYHAclassI/II:

84.1%1年生存率:

85.8%TranscatheterAorticValveReplacementforDegenerativeBioprostheticSurgicalValvesResultsFromtheGlobalValve-in-ValveRegistry.DannyDvir,etal.Circulation(2012)GlobalValve-in-ValveRegistry2012

n=202TranscatheterAorticValveReplacementforDegenerativeBioprostheticSurgicalValvesResultsFromtheGlobalValve-in-ValveRegistry.DannyDvir,etal.Circulation(2012)JValve豬瓣自膨脹定位鍵活動式連接解剖性定位穩(wěn)固的錨定

DevicesforARJenaValveTMsystem(JenaValveTechnologyGmbH,Munich,Germany)TheEngagerTMAorticValvebioprosthesis(Medtronic,Inc.,Minneapolis,MN,USA)J-Valve和用于主動脈瓣反流的其他瓣膜的區(qū)別定位鍵和瓣膜之間的連接是可活動的;定位鍵到位后瓣膜位置仍可以調(diào)整;上下方向調(diào)整，軸向位置調(diào)整.定位鍵和瓣環(huán)形成一種”鑰匙和鎖”的關(guān)系。MitraClip

systemAbbottVascular,SantaClara,CaliforniaFDA批準的適應(yīng)癥有癥狀的原發(fā)性二尖瓣反流且無法耐受手術(shù)(2013)功能性二尖瓣反流尚在進一步論證中(COAPTTRIAL)正在進行中的臨床試驗COAPT(2012)有心衰癥狀的病人合并中重度或重度功能性二尖瓣反流HiRiDe(2015)退行性二尖瓣反流的高危和中危病人MITRA-FR

(2013)嚴重的繼發(fā)性二尖瓣反流TMVRTranscatheterMitralValveReplacementValve-in-valveValve-in-ringIncalcifiednativemitralvalveInnoncalcifiedfunctionMR2007201320112014TMVR發(fā)展的時間軸TMVR專用瓣膜Fortis,EdwardsLifesciences,Irvine,CaliforniaTiarasystem,NeovascInc.,Richmond,BritishColumbia,CanadaTMVR專用瓣膜CardiAQTM(CardiAQValveTechnologies,Irvine,CA,USA)Tendynemitralpros-thesis(TendyneHoldings,Roseville,Minnesota)Fortissystem植入過程TranscatheterDVRTranscatheterDVRFirst-In-ManSimultaneousTranscatheterAorticandMitralValveReplacementto

TreatSevereNativeAorticandMitral

Valve

Stenoses.JACCCardiovascInterv.WitkowskiA,etal.2015Aug24;8(10):1399-401.PPVIPercutanousPulmonaryValveImplantationFDA以批準瓣膜TheMelodyvalve(MedtronicInc,Minneapolis,Minnesota)新一代瓣膜VenusP,VenusMedtech,Hangzhou,ChinaSuturelessValve為什么選擇suturelessvalve不僅僅是為了縮短主動脈阻斷時間小瓣環(huán)中做到更大的EOA微創(chuàng)手術(shù)路徑再次手術(shù)商業(yè)化應(yīng)用的瓣膜ThePercevalsuturelessvalveprosthesis(SorinGroupItaliaS.r.l.,Saluggia,Italy)ATS3fEnablebioprosthesis12(ATS,Minneapo-lis,Minn)商業(yè)化應(yīng)用的瓣膜EdwardsIntui