2021ACCF/AATS/SCAI/STSExpertConsensusDocumenton

TranscatheterAorticValveReplacement

經皮主動脈瓣置換專家共識歷史背景主動脈瓣狹窄常見于老年〔﹥75歲〕的主動脈瓣鈣化、風濕性心臟病和先天性二葉瓣。主動脈瓣狹窄會逐漸進展，左心室壁肥厚，最終導致左心衰竭。一旦出現(xiàn)病癥，預后極差。從病癥出現(xiàn)到死亡的平均時間：心衰2年，昏厥3年，心絞痛5年。藥物治療1、2年死亡率為25％、50％。嚴重主動脈瓣狹窄的定義對于左心室收縮功能正常的患者：主瓣峰值血流速度>4.0m/s(對應跨主瓣峰值壓差64mmHg),平均壓差>40mmHg,或主瓣瓣口面積<1.0cm2.考慮到患者體外表積不同，主瓣面積常用體外表積指數(shù)表示，≤0.6cm2/m2作為嚴重主瓣狹窄的標準.嚴重主動脈瓣狹窄的治療選擇嚴重主動脈瓣狹窄的治療選擇嚴重主動脈瓣狹窄的治療選擇嚴重主動脈瓣狹窄的治療選擇二、Balloonaorticvalvuloplasty.預后較差。Restenosisorrecoiloftheaorticvalveusuallyoccurswithin6months.Patientstreatedwithballoonaorticvalvuloplastyalonehaveshownpoorprognosis,withsurvivalratesof50%at1year,35%at2years,and20%at3years.Inaddition,seriouscomplicationsduetoballoonaorticvalvuloplastyoccurin15%to25%ofpatients。嚴重主動脈瓣狹窄的治療選擇歷史：1992開始動物實驗；2002年實現(xiàn)經皮置入人體第一個可擴張的馬心包支架瓣膜。之后多種TAVR瓣膜問世。DeviceDescription：〔一〕Sapienvalve(Figure1)EdwardsLifeSciences,Inc.,Irvine,CA)：三瓣牛心包瓣固定在可球囊擴張的鈷鉻合金支架上。TheSapienvalveisavailablein23-mmand26-mmsizesintheUnitedStatesand23-mm,26-mm,and29-mmsizesinEurope.Theinitialdevicesrequireda22-or24-Frenchsheathfordeliveryoftheprosthesis.Recentiterations(NovaFlex)havedecreasedthisto18-French.

Sapienvalve〔二〕CoreValve(Figure2)(Medtronic,Inc.,Minneapolis,MN).三片豬心包固定于可自膨脹的鎳鈦合金支架上。CoreValve：Itisavailablein3sizes—26mm,29mm,and31mm.Thisvalvehasalsocontinuedtoiterate,withtheinitialdevicesbeing25-French,butnow18-Frenchdeliverysheathsareused.Thisvalvehasonlybeenusedbyaretrogradeapproach—eitherviatransfemoral,subclavian,ordirectaorticaccess.Anestimated40,000patientshavereceivedTAVRworldwide.Multiplesingleandmulticenterregistries,andasinglerandomizedtrial,havedocumentedfavorableoutcomesusingawidespectrumofendpoints,includingsurvival,symptomstatus,qualityoflife,andneedforrepeathospitalization.ThereareonlylimitedclinicaldataonthedurabilityofTAVRvalves—upto2years—inthePARTNERtrialandupto5yearsinotherregistryexperiences.Table1.EdwardsSapienTranscatheterHeartValveRegistriesTable2.MedtronicCoreValveTranscatheterHeartValveRegistriesRandomizedControlledTrial

－PARTNERTrialDesignAprospective,unblinded,randomized,controlled,multicenterpivotaltrialevaluatingthesafetyandeffectivenessoftheEdwardsSapienTHVtranscatheteraorticvalve;2distinctpopulationswereenrolled—

CohortA-high-riskoperable,699人;CohortB–inoperable,358人;

PARTNERTrialDesign表3人口基線特征Table4.MajorOutcomesat30Daysand1YearinCohortBofthePARTNERTrialTable6.MajorOutcomesat30Daysand1YearinCohortAofthePARTNERTrialTable7.QualityofLifeandSymptomAssessmentinTAVRTrialsTable9.PatientSelection:InclusionandExclusionCriteriainClinicalTrialsTable9.PatientSelection:InclusionandExclusionCriteriainClinicalTrialsTAVR所需圖像設備心臟彩超CT心臟磁共振觀察主動脈瓣、瓣環(huán)、瓣環(huán)距冠狀動脈的距離、升主動脈、髂股動