冠狀動脈介入治療的球囊和支架的應(yīng)用,中國醫(yī)學(xué)科學(xué)院阜外心血管病醫(yī)院高展,冠狀動脈介入治療球囊的選擇,球囊分類,整體交換球囊（OTW-overthewire)快速交換球囊(monorail),球囊的結(jié)構(gòu),球囊尖端球囊推送桿,球囊尖端,外徑：直頭圓弧錐形尖端與球囊的連接：膠水黏結(jié)熱焊接激光焊接,球囊,球囊材料：尼龍、聚乙烯球囊順應(yīng)性折疊方式：三層折疊：利于回卷，后撤，低折疊減小通過半徑標記方式：中央標記易于通過嚴重狹窄病變，雙標記利于測量病變長度球囊肩部角度：球囊于尖部平滑過渡有利于通過病變球囊與中心桿的連接技術(shù)和材料：決定通過扭曲血管的能力,球囊性能,外徑（crossingprofile)靈活性（flexibility)跟蹤性（trackbility)推送性（pushbility)順應(yīng)性（compliance),球囊操作要領(lǐng),預(yù)擴張,有利于支架的植入有利于病變的測量選擇小于血管直徑0.5-1mm的球囊進行預(yù)擴張，球囊長度應(yīng)適當預(yù)擴張應(yīng)盡量減少對正常血管的損傷為測量病變長度，使預(yù)擴張球囊在冠狀動脈內(nèi)進行造影時，注射造影劑的力度不宜過大，以免加重血管的撕裂對于狹窄程度重、較復(fù)雜的病變，預(yù)計支架通過較困難的病變應(yīng)常規(guī)充分地預(yù)擴張，尤其對初學(xué)者,后擴張,防止支架貼壁不良，預(yù)防支架內(nèi)血栓形成，降低再狹窄后擴張球囊可選擇大一號的球囊或更高的壓力后擴張時一定不能超出支架的邊緣，尤其是的DES不可盲目追求所有病例的大球囊高壓力的后擴張，以免增加無再流和冠狀動脈破裂的風險,不同類型病變的球囊選擇,CTO病變：常選擇單標記、整體交換、小外徑（1.5mm）球囊，如Maverick等長病變：原則上選用較長的球囊，以防兩端撕裂并減少擴張次數(shù)。分叉病變：可選雙導(dǎo)絲球囊、切割球囊。目的：減少斑塊移位、降低分支閉塞的概率。,不同類型病變的球囊選擇,小血管病變：宜選用外形小，推進性好的球囊。還可選用耐高壓球囊。扭曲病變：應(yīng)選擇外形較小、推進性好的球囊。OTW球囊推進性較單軌球囊好，還有利于交換導(dǎo)絲鈣化病變：應(yīng)選擇外形較小、推進性好的球囊。還可選用雙導(dǎo)絲、耐高壓乳突或切割球囊。,常用的球囊特點,MaverickPTCABalloonCatheters,ProprietarylaserbondedtechnologycreatesanextraordinaryTrakTipDesignandprecise,smoothbondsthroughouttheshaft.Pushcoildesignandimproveddistalflexibilityforenhancedtrackability.Our1.5and2.0mmSoftLEAPBalloonsofferenhancedcrossability.,ApexPTCADilatationCatheter,SlopeOuterShaftsmoothlytransitionsfromstifftoflexible,allinonepiece,formoreefficientpushtransmissionBi-SegmentInnerShaftoptimizesthebalancebetweenpushandtrackShorter,thinnermarkerbandsincreasedistalflexibilityRedesignedtipwithimprovedflexibilityandwiremovement;sameultra-low0.017profileOptiLEAPBalloonwithreducedwaistthicknessprovidesgreatsizingflexibilitywithlowerprofilesNano-compositematerialsaddsstructureandpushabilitytotheoutershaft,QuantumMaverickBalloon,Lowprofile,fulllength1.8For2.0FMonorailshaftLowprofile3.2Fproximalover-the-wireshaftBioslideCoatingonaPEBAXDistalShaftLaserbondingtechnologyQuantumLEAPBalloonMaterialTaperedTrakTipDesignwith.017lesionentryprofile*,QuantumMaverickBalloon,NCsprinter,外形細小的FasTrac頭端技術(shù)-可在遇到較難通過的病變時提供極佳的通過能力；柔軟耐用的FulcrumPlus球囊材料和MiniWrap折疊技術(shù)提供細小的外徑和出色的再回抱能力；選擇性的Dura-Trac涂層使球囊在到達和通過病變的過程中保持持久的潤滑，在球囊擴張時保持穩(wěn)定；漸細鋼絲設(shè)計的推送桿增強了球囊的跟蹤能力和通過遠端病變能力；光滑細小的導(dǎo)絲交換口使3.5mm以下的任何兩個球囊可在6F（0.070）的指引導(dǎo)管里對吻。,SunflexTipissuperblyengineeredtogiveaperfectbalancebetweenflexibilityandkinkresistance.Zerotransitionbetweenthetipandwireforsmoothestentryprofile.TaperedTip:ThetaperedsofttipcombinedwithadvancedlaserweldingtechnologyprovidesthemostcompetitivetipprofileSlidematrixdualcoatingisspeciallyformulatedwithtwouniqueproprietaryblends.HydrophilicandInviocoatingsareappliedtothedistalleadingtipsectionandtheballoon/shaftsection,respectivelytoprovideanoptimalbalancebetweenlubriciouscrossingandminimizingwatermelonseedingTightFoldprocessingresultsinaslenderprimaryprofileforenhancedcrossabilitythroughtightlesions.SapphireNC,OrbusNeich,TheIPTransitionZoneoftheAvitaPTCADilatationCatheterprovidesintensifiedpushability.Thenewtaperedtipdesignwithsoftmaterialexhibitsaflexibletipforsmoothlesionentryandminimalvesseltrauma.TheInviocoatingontheinnerlumeneliminatesfrictionbetweenthecatheterandguidewire.Invioisalsoappliedtotheouterdistalsegmentfromthetiptotheexitmarkerzoneforlubriciouscrossability.AvitaHP,OrbusNeich,Rugin,CrossTipTM確保Ryugin通過性可以達到的最高性能。CrossTipTM是由特殊混合的彈性塑料聚合物制作而成。0.017英寸(0.043毫米)的入口外徑確保了Ryugin在完全閉塞的病變的復(fù)雜管腔里的通過性。CrossTipTM中等長度的柔韌前端能較易地通過移植支架處的病變并繃緊其鈣化病變。親水涂層M-Coating，塑料聚合物的復(fù)合層和新一代金屬合金的Hypotube。使用Ryugin通過過度彎曲和大彎曲血管時，它能順滑的到達目標病變部位，并且成功的處理其復(fù)雜閉塞病變。提供廣泛有效的球囊直徑選擇范圍從超細的1.25毫米直徑到4.0毫米直徑不等。薄型聚酰胺球囊確保了其卓越的通過性RyuginCrossTip是從尖端到薄型聚合物球囊的一段平滑過度部分，平滑柔韌的聯(lián)合體能夠通過各種復(fù)雜病變部位。泰爾茂新一代FC(FlexibleCorrugate)軸管成為連接高彈性的前端軸管和具備強硬金屬的Hypotube軸管之間的橋梁。FC-shaft是指經(jīng)過加工的柔軟的膠質(zhì)軸，該技術(shù)實現(xiàn)了通過一個平衡軸加強力量的傳輸性和彈性。,Voyager,SuperbCrossTaperedTipDesignNewtaperedtipwith.017”tipentryprofiledesignedtocrosstightlesionsImprovedtip-to-wireconformability1forconfidenttrackandcrossPolyurethanetipmaterialisflexibleyetdurablefortoughlesionsFlexibletungstenmarkertechnologyallowscathetertoconformtotortuousanatomyMoreOptionsLowProfileShaftDesignVersatiletreatmentina6FguideExcellenttrackandpushintortuousanatomywithnewhypotubedesignReinforcedmid-shaftdesignprovidesflexibilityandadditionalsupportFlexibilitywithVisibilityProprietaryTungstenMarkerNewmarkermaterialcomprisedoftungstenpolymerFlexiblemarkerdesignallowsthecathetertoconformmoreeasilytotortuousanatomyIncreasedmarkerflexibilityhelpstoreduceresistancewhencrossingtightlesionsPreciseDilatationProvenBalloonPerformanceShorttapersallowforprecisedilatationImprovedLOFOLDBalloonTechnologyprocessesallowsforexcellentrewrapandrecross1XCELONSBalloonMaterialachievessuperbflexibility,Powersail,PLATEAUBalloonMaterialProvidesnon-complianceathighpressurewithoutcompromisingperformanceFlexibilityandconformabilityforexcellentdeliverabilityLOFOLDBalloonTechnologyProvidesalowcrossingprofileforexceptionallesioncrossLOFOLDballoontechnologyforimprovedballoonrewrapSoftTipDesignTaperedtipdesigncreatesalowentryprofileandexcellenttip-to-wireconformabilityforeasylesionaccessSofttipprovidesflexibilityfornegotiatingtortuosityandcrossingstentstrutsDualSwagedMarkersProvidelowerprofilesthanconventionalmarkers,SafeCutusesdualwiremechanismtocreatefocusedforce.Ithasabuilt-in0.011integralwireexternaltotheballoontohelptracktortuousvesselswithgreatefficiency.Astandard0.014guidewirethatdeliversthecathetertothetargetlesionalsoparticipatesinthedilatationprocess.Theguidewireexitportislocatedattheproximalpartoftheballoon.Duringballoondilatation,thestandardguidewireandintegralwireapplycontrolledforcetofacilitateplaquefracturesatlowinflationpressures.Thesameapplicationalsohelpsminimizeballoonslippage.SafeCutsdistalleadingtipprofileis0.032taperedto0.028whichissmallerthanthoseofotherfocusedforceballoons.Balloonswithembeddedbladesforscoringthevesselhavehighcrossingprofilesduetothenatureoftheballoonmaterialsandblades.Theintegralwireandstandardguidewireapplyevenlydistributedforcetofacilitatecontrolledplaqueatlowpressures,reducingtraumatothevesselwall.Otherballoonsusingthesamefocusedforcetechnologyusebladeswhicharemuchmoretraumatictothevesselwall.,OrbusNeich,CuttingBalloon,TheFlexibilityYouWantNylonballoonmaterialdesignedtoprovideflexibility,superbcomplianceandimprovedpunctureresistanceOverallbetterdeliverabilitytotreatmorecomplexlesions.TheDeliverabilityYouNeed30%moreDeliverablethantheCuttingBalloonUltra2Device*50%improvementinre-crosscomparedtotheCuttingBalloonUltra2Device*ThePredictabilityYouRelyOnPrecisedilatationScoringtheplaquebyseveringtheelasticandfibroticcontinuityofthevesselwallDilatingthelesionatlowerpressureswithlessrecoilLumengainthroughplaquecompressioninsteadofvesselwallexpansion,冠狀動脈介入治療支架的選擇,冠狀動脈支架廣泛應(yīng)用的原因,植入支架后影像好，急性期結(jié)果好支架能夠治療急性或瀕臨閉塞，安全性明顯提高支架降低再狹窄率，改善患者的長期預(yù)后植入支架容易操作支架的應(yīng)用可以減少操作時間對于復(fù)雜病變，球囊擴張結(jié)果往往不理想，植入支架可以得到滿意的結(jié)果,支架分類,根據(jù)設(shè)計不同，分為網(wǎng)狀支架、管狀支架、纏繞型支架、環(huán)狀支架。根據(jù)材料不同，分為316L不銹鋼支架、鈷支架、鉻支架、鎳支架、鉭支架。根據(jù)輸送方式的不同，分為球囊膨脹性支架和自膨脹性支架。根據(jù)特殊用途而設(shè)計不同的支架，如適合分叉病變的支架和適合分支的支架以及針對冠狀動脈瘤或穿孔的帶膜支架根據(jù)是否帶藥，分為藥物涂層支架和非藥物支架,支架的性能特點,支架的開環(huán)和閉環(huán)設(shè)計,網(wǎng)眼大小,微米,支架絲厚度,金屬動脈比值,支架可視性,裸金屬支架選擇原則,針對不同病變和支架的特性選擇不同的支架支架的直徑與參照血管的直徑比為1.0-1.1長度將病變或夾層全部覆蓋避免過長支架和一支血管植入多個支架，多個支架不可避免時應(yīng)可能減少支架過多重疊,CordisConfidential-InternalUseOnly,藥物,聚合物,支架,雷帕霉素和紫杉醇理想藥物,聚合物最理想的釋放系統(tǒng),支架平臺封閉單元式設(shè)計,藥物洗脫支架,回縮和重塑,內(nèi)膜增生,結(jié)果:安全性,療效性,輸送性,DES與BMS的比較,早期的臨床試驗隨訪4年結(jié)果表明，DES與裸金屬支架（BMS）比，明顯降低再次血運重建率，但死亡和心肌梗死（MI）兩者沒有差別。針對特定亞組患者的隨機臨床試驗，如支架內(nèi)再狹窄、慢性完全閉塞、糖尿病、小血管病變，也都證明了DES的優(yōu)越性。但是由于這些標簽外應(yīng)用“off-label”的臨床試驗隨訪時間較短、樣本量較小，對發(fā)生率較低的支架內(nèi)血栓、死亡、MI這些終點事件無法鑒別，故對于DES應(yīng)用于這些標簽外指征尚無定論。,DES與BMS的比較,DES因為有涂層（polymer），所以較硬，順應(yīng)性和輸送性較差，故對置入較困難的病變應(yīng)選擇BMS。DES較BMS昂貴，對于經(jīng)濟困難的患者應(yīng)首選BMS。對于那些容易發(fā)生再狹窄的病變應(yīng)選擇DES。,建議的分類,介入治療有用、有效證據(jù)偏向有用、有效有效的證據(jù)不充分介入治療無效，甚至可能有害,Recommendation,原位病變（DeNovo）,ACC/AHA2005GuidelineforPCI,ACC/AHA2005GuidelineforPCI,-金屬支架內(nèi)再狹窄(vs.brachytherapy)-分叉病變(主支置入藥物支架,分支PTCA或provisionalDES)-開口病變-慢性完全閉塞-多支血管病變(合并糖尿病)-靜脈旁路血管病變,ACC/AHA2005GuidelineforPCI,ACC/AHA2007guidelineupdateforPCI,預(yù)擴張,如果預(yù)計支架植入困難，必須充分預(yù)擴張，以防止藥物支架的涂層的損壞和支架的脫載如預(yù)計支架植入不會太困難，保證最小損傷措施包括：選擇小一號的球囊（小0.5-1.0mm）短球囊（重點擴張最狹窄處并保證球囊長度永遠短于擬用的DES支架長度）使用低壓力預(yù)擴張（8atm）也可以選擇使用穩(wěn)定性好的短球囊（cuttingballoon或safecut）直接支架,藥物支架選擇和擴張,了解所有有關(guān)藥物支架的技術(shù)規(guī)格說明支架直徑的選擇應(yīng)基于對造影圖象中血管的估測或定量的血管內(nèi)超聲圖象的測量影像標準：支架的球囊:血管直徑=1.1:1IVUS標準：應(yīng)參考參照血管直徑（如是漸細的血管，取近遠段參照血管直徑的平均值）,支架選擇和展開,長度選擇應(yīng)強調(diào)支架“無病”區(qū)到“無病”區(qū)（或近段正常參照血管段到遠段參照血管段），即支架應(yīng)較病變長3-5mmIVUS和帶有標記的引導(dǎo)鋼絲對于選擇藥物支架的長度有幫助在裸金屬支架時代，“越大越好”獲取最大的術(shù)后最小管腔直徑以抵消晚期管腔丟失（即顯著的內(nèi)膜增生）在藥物支架時代，“長一些更好”保證病變的全部覆蓋,藥物支架選擇和展開,輸送藥物支架過程中應(yīng)避免用手接觸支架過止血閥時，應(yīng)充分打開，以防止對藥物支架涂層的磨損如果藥物支架難以跨過病變，避免過度用力推送，最好再次擴張后再次推送,后擴張,并非所有病例中應(yīng)用的藥物支架置入后都需要后擴張藥物支架極低的晚期管腔丟失，沒有必要像以往過度追求的造影效果；但是，應(yīng)該選用另一個球囊擴張任何支架內(nèi)不能被接受的狹窄或支架腰后擴張的球囊應(yīng)該總是被定位于藥物支架邊緣以內(nèi)（即總是用短于支架的后擴張球囊)后擴張球囊大小不應(yīng)超過兩個數(shù)量級,IVUS的重要性,支架置入前的應(yīng)用（預(yù)擴張前或后）評價病變長度和血管漸變程度（包括參照血管內(nèi)的病變）評價血管的大小評價病變與開口或分支血管的位置關(guān)系評價病變的形態(tài)學(xué)（可能影響預(yù)擴張或后擴張的策略）支架置入后的應(yīng)用評價是否所有支架絲與血管壁完全貼附評價已被支架覆蓋的區(qū)域（適當?shù)闹Ъ艽笮∈欠褙灤┱麄€病變）評價是否支架已覆蓋全部病變對于多個支架-檢查重疊區(qū)域以避免空隙,目前常用的藥物支架特點,CYPHERSirolimus-elutingCoronaryStent,TAXUSExpressCoronaryStent,AProvenStentTheExpress2Stentplatformoffersexcellentdeliverabilityandconformability.AReliablePolymerTheTAXUSExpressStentusesTranslutePolymer,aproprietarypolymercarriertechnology,tocontroldrugrelease.AnEffectiveDrugTheuniquepropertiesofpaclitaxelcontributetotheefficacyoftheTAXUSExpressStent.Paclitaxelsmulti-functionaleffects,stabilizemicrotubulesandinhibitactivitiesthatcontributetorestenosis.3Paclitaxelishighlylipophilic,whichmaycontributetomoreuniformdrugdistribution.4,316L不銹鋼材料支架梁厚度0.0038”尖端外廓0.017”通過外廓0.047”*,PicturestakenbyBostonScientific.,改善的通過性*,*Fora3.0mmstent,PicturestakenbyBostonScientific.,*BasedoninternalbenchtestsofthefeaturesoftheLibertStentcomparedtoExpressStentandmarketresearchresults.Dataonfile.,TAXUSLibert支架系統(tǒng)改善的輸送性和順應(yīng)性,增強的TrakTip尖端,5折球囊技術(shù),增強的TrakTip尖端外廓極小,提供了更好的病變通過和改善的跟蹤性.*,該設(shè)計減少了支架的旋轉(zhuǎn),增強了支架的固位.,改善的輸送性和順應(yīng)性*,PicturetakenbyBostonScientific.,*BasedoninternalbenchtestsofthefeaturesoftheLibertStentcomparedtoExpressStentandmarketresearchresults.Dataonfile.,TAXUSLibert支架系統(tǒng)改善的輸送性和順應(yīng)性,支架平臺比較血管覆蓋,TAXUSLibert支架,TAXUSLibert支架的小的單元面積設(shè)計可以保持出色的血管覆蓋和支持,同時減少組織下垂的危險*.,Cypher支架,TAXUSExpress2支架,*Cellareavariabilitybaseduponstentdiameter.ImagestakentakenbyBostonScientificof3.0mmdiameterstents.CypherisatrademarkofCordisCorp.DriverisatrademarkofMedtronic/AVE.,CypherSelect支架,Driver支架,命名壓力,額定爆破壓力,命名壓力,TAXUSLibert支架系統(tǒng)支架順應(yīng)性圖表,ATM直徑(mm)2.252.502.753.03.582.762.973.4392.192.442.813.023.49102.242.492.873.083.56112.292.552.933.143.63122.322.592.983.193.68132.362.643.023.233.73142.392.673.063.273.78152.422.703.093.313.81162.442.743.123.343.85172.742.763.143.373.882.492.793.173.393.92,NominalpressureforTAXUSExpress2:9ATM,Caution:Thisisaninvestigationalde