切割球囊(1)

1BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally波士顿科学明星产品一Flextome™波士顿科学2BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally2AgendaFlextome™设计特点Flextome™工作原理Flextome™适应症Flextome™使用技巧3BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally3AgendaFlextome™设计特点Flextome™工作原理Flextome™适应症Flextome™使用技巧4BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternallyFlextome™切割球囊的球囊设计球囊（非顺应性球囊上纵向镶嵌固定显微刀片）•尼龙材料•非顺应性•头端外径0.020“•两个1mm宽的嵌入式Marker•NBP：6ATMRBP：12ATM5BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternallyFlextome™切割球囊的球囊设计显微刀片•底端T-型槽口设计•每5mm有1个0.004“的Flexpoint•2—3.25mmballoon:3个刀片•3.50—4mmballoon:4个刀片6BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternallyFlextome™切割球囊的球囊设计显微刀片•工作高度0.005“/0.127mm（全高0.011”-0.013”）6ConfidentialPropertyofBostonScientific--DoNotCopyorDistribute•Totalheight—0.011”/0.2794mm-0.013”/0.3302mm•Workingheight(scoringedge):atleast0.005”/0.127mm•.004”/0.1016mmflexpointlocatedevery5mmFlextomeCuttingBalloonDeviceAtherotome.005”/.127mmCoronaryStentStrutHumanHair.003”/0.0762mmFlextomeTMCuttingBalloonTMDeviceComponentsAtherotomes–bladeheight7BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally7AgendaFlextome™设计特点Flextome™工作原理Flextome™适应症Flextome™使用技巧8BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternallyFlextome™切割球囊™工作原理非顺应性球囊可以在较低的应力下进行扩张2,4,5主要通过挤压斑块和轻度扩张血管壁取得来使血管管腔受益2,7,8显微刀片截断病灶部位管壁的弹性和纤维连续性1，减少斑块的轴向迁移3-4个刀片均匀分布，规则有序的切开斑块，减少不规则夹层的发生1Bonan,JInvasivCardiol,1999;11:2302Haraetal.,AmJCardiol2002;89:1253-12564Ergeneetal,JInvasCardiol1998;10:70-75刀片设计T-型底端槽口设计能增强刀片的灵活性和与球囊连接的稳固性工作高度（切割边缘）0.005”/0.127mm5GlobalRandomizedTrial-CuttingBalloonDeviceDirectionsforUse;DataonFile6Inoueetal.,Circulation,1998;97:2511-2518(USSCI#2392)7Yamaguchietal.,JIntervenCardiol1998;11(Suppl)S114-S1198Suzukietal.,AmerJCardiol1999;84Suppl:58P(USSCI#2525)9Taniuchi,etal.TheWINNERRegistryCatheterCardiovascInterv2004;62:C–369BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally•Createscontrolledincisionplaneswhichhelptorelievehoopstress•AllowsdilatationatlowerpressuresCBPOBAFlextome™切割球囊™工作原理通过挤压斑块和轻度扩张血管壁来使血管管腔受益急性期14天后10BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally切割球囊VS.双导丝球囊CuttingBalloon2.0-4.0mm/10mm/6-12ATMScoreflex2.0-4.0mm/10&15mm/6-16ATM切割工具厚度0.005”0.011”切割工具材料显微手术刀片金属导丝切割段数量31切割段幅度广狭窄切割段形状三角形线状/表浅/细小球囊通过性中等较好球囊工作压力较低较高OCT图像3.0mm10ATM2.0mm16ATM11BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally麦秆试验扩张效果对比——切割球囊VS.双导丝球囊12BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally12AgendaFlextome™设计特点Flextome™工作原理Flextome™适应症Flextome™使用技巧13BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally13Flextome™切割球囊™是唯一获得FDA批准的特殊球囊适应症：支架内再狭窄病灶–避免球囊滑脱口部和分叉位置*病变–避免斑块迁移纤维化病变–改变病灶的顺应性Flextome™切割球囊™系统是一种独特**且有效***的工具，适用于传统球囊血管成形术无法应对的复杂病灶14BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally14ISR•目的:•对比切割球囊™系统+支架和传统球囊血管成形+支架手术后血管造影下血管再狭窄率的降低幅度•主要研究人：•TakahikoSuzuki，MD，丰桥心脏中心/丰桥，日本•前瞻性、随机、多中心研究（38个研究中心）•521例患者•终点：•6个月时的临床急性并发症情况和目标病灶血运重建（TLR）•6个月时的血管造影下血管再狭窄情况手术数据切割球囊系统+支架（n=260）POBA+支架（n=261）P值血管造影成功率100%100%ns手术成功率98.5%100%ns最大扩张应力7.20atm8.88atm0.001MLD（术前）1.05mm1.01mm0.100MLD（术后）2.65mm2.52mm0.002MLD（随访期）1.86mm1.77mm0.068管径狭窄（术前）62.6%63.9%0.137管径狭窄（术后）14.0%16.3%0.001管径狭窄（随访期）32.4%35.4%0.039其他6个月随访期时的数据TLR9.6%15.3%0.048总MACE11.5%16.8%0.082再狭窄率11.8%19.6%0.024MLD，最小管腔直径；TLR，目标病灶血运重建；MACE，主要心脏不良事件；MACE的定义：SAT，亚急性支架血栓；LST，迟发急性支架血栓；死亡；MI：心梗；TLRREDUCEIII临床试验11请参阅参考文献。15BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally球囊滑动导致的并发症由于球囊滑动，因此普通球囊可能导致•D-F型夹层风险更高higherpercentageofdissectionsD-F•可能需要多放一个支架higherpercentageofadditionalstenting切割球囊可以精准的锚定和直接对抗病变，避免球囊滑动RESCUTdatabase16BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally口部病变的特点:弹性程度较高和移动效应大•“Ostiallesionsareoftenfibrotic/elasticandcancausecomplicationsbecauseofrecoilandspasm.12”MathiasDWetal.Frequencyofsuccessandcomplicationsofcoronaryangioplastyofastenosisattheostiumofabranchvessel.AmJCardiol.1991Mar1;67(6):491-5.17BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally切割球囊™系统与普通球囊相比弹性回缩小切割球囊系统处理口部病灶的主要结论：•可减少弹性回缩4•斑块受到的挤压更多，几乎无斑块迁移且血管伸展极少5,6,7•最大化管腔受益13ReductionofEarlyElasticRecoilbyCuttingBalloonAngioplastyasComparedtoConventionalBalloonAngioplasty。JInvasiveCardiology18BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally分叉病变--减少斑块迁移和边支丢失“雪橇效应”——斑块的轴向移位19BostonScientificConfidential--ForInternalUseOnly.DoNotCopy,DisplayorDistributeExternally边支闭塞-Case•斑块迁移可导致边支闭塞•临床后果–心绞痛–心肌梗死–死亡。。20BostonScientificConfidential--ForInternalUseOnly.DoNot