颈动脉介入治疗课件.ppt

1、颈动脉介入治疗中枢神经的供血特点大脑的能量供应只能依靠血糖,自己没有能量储存.故其重量约为体重的2%,血供却占心输出17%(平均750ml/min);氧气消耗的20%(平均46ml/min).双重供血体系,并以基底动脉环为基础,建立较广泛的側枝循环.The Thoracic Aortogram颈动脉分叉Whats wrong here?Circle of Willis颈动脉疾病脑卒中发病率:200/100.000 每年80%缺血性50%有颈动脉狭窄中国每年80-200(120)万新发病例(0.1%)第三位死因80%临床症状由缺血所致(50%无症状颈动脉狭窄 70%需要有创治疗CEA危险因素Ne

2、w et al,Comp.Ther.1999,25:438-445对ACAS/NASCET研究的反对意见 由非常好的外科医生实施许多排除标准，可被认为是低风险的病人，例如没有合并症一般被认为是理想的外科医生治疗理想的病人成功完成随机临床试验(e.g.SAPPHIRE)，导致接受支架置入术为一种治疗方法，FDA 批准适应征和报销医生教育以增加能够安全完成操作的熟练操作者数量临床试验必须证明对高风险病人的疗效与CEA 等同继续研发易于使用的远端保护装置并将其整合入颈动脉支架系统市场/程序开发资源(全球和局部展开).发展并展开理解颈动脉操作和临床问题的核心能力接受接受CSSA的障碍的障碍缺少真实的临

3、床资料有许多单中心经验显示极好的结果(Mathias,Roubin,TCT 2002)早期的实验不能反映现状，Wallstent RCT(7F Easy Wallstent no EPD)CAVATAS,(No Stenting,No EPD)所有的工业试验都是注册的，没有对照因此需要颈动脉腔内介入治疗颈动脉内膜切除术高风险病人使用保护装置的支架和血管成型术一年随访结果(The SAPPHIRE Study-1year results)SAPPHIRE科研实验执行委员会员Jay Yadav,MDAngioguard脑保护伞的发明者顾问公司或股东:JNJ强生公司，Guidant,CadioMEM

4、SSAPPHIRE研究者SAPPHIRE研究者执行委员会Jay S.Yadav,MD 心脏科医师Mark Wholey,MD 放射科医师Barry Katzen,MD放射科医师Kenneth Ouriel,MD血管外科医师Pierre Fayad,MD神经科医师数据分析数据管理：Harvard Clinical Research Institute(HCRI)CEC DSMB 质量控制中心实验室：Jeff Popma(Brigham&Womens)超声中心实验室：Mike Jaff(VasCore)经济学分析：David Cohen(HCRI)过滤装置分析：Renu Virmani(AFIP)

5、赞助：Cordis Corporation研究概述随机的，多中心试验，对高风险外科手术病人，使用保护装置的支架介入术和内膜切除术对照研究非随机的病人进入支架注册组或外科手术注册组使用的产品为Cordis公司的 PRECISE 镍钛支架系统和ANGIOGUARD XP 远端保护装置29 个研究地点SAPPHIRE 50%狭窄（有症状）80%狭窄（无症状）一个或多个合并症标准医生小组构成:神经科医师，外科医师，介入医师一致同意一致同意 随机随机 334（310人被治人被治疗疗）支架支架=159 CEA=151支架注册支架注册406外科拒绝外科拒绝外科注册外科注册7介入拒绝介入拒绝 研究概述（续）随

6、访时间：l30天 l6 月l1 年 l2 年l3 年初级终点术后30天时的死亡，中风，心肌梗死 30 天主要不良临床事件以及术后31天至12月的死亡和同侧中风统计学假设通过比较颈动脉支架置入术与内膜剥脱术的疗效与安全性来证明支架置入术不次于内膜剥脱术（-3检验标准）关键入组标准有症状，狭窄 50%（超声或血管造影）无症状，狭窄 80%（超声或血管造影）有症状和无症状的病人分层自然形态的颈总动脉或颈内动脉 多学科小组一致同意外科医师，神经科医师，介入医师 关键入组标准（续）病人必须有一种或多种下述情形，使他们处于外科高风险条件：-充血性心力衰竭(III/IV级)和/或已知的严重左室功能不全 LV

7、EF 24 小时 and 0.99冠状动脉疾病冠状动脉疾病85.2%73.9%0.02*先前有先前有Q或无或无Q心心肌梗死肌梗死29.7%34.7%0.38先前先前CABG43.4%23.8%0.99 中风史中风史 27.0%24.0%0.60 TIA 史史 31.0%32.4%0.81 先前先前 CEA 28.9%23.8%0.37 COPD 18.4%10.3%0.07 高血压病史高血压病史 86.1%85.4%0.87 糖尿病史糖尿病史 25.8%26.7%0.90 高血脂病史高血脂病史 79.5%78.7%0.89 支架注册人口统计学特征 平平均均年年龄龄 71.4%男男性性 64.3

8、%冠冠状状动动脉脉疾疾病病 68.9%先先前前有有 Q 或或无无Q 心心肌肌梗梗死死 33.4%先先前前 CABG 31.5%先先前前 PTCA 21.2%CCS III or IV 31.5%支架注册人口统计学特征（续）临床充血性心力衰竭临床充血性心力衰竭 18.2%中风史中风史 32.3%TIA 史史 34.5%慢性阻塞性肺疾病慢性阻塞性肺疾病 18.0%高血压史高血压史 84.4%糖尿病糖尿病 30.8%高血脂病史高血脂病史 73.9%病人进入情况注册支架病人:406注册CEA:7随机“预治疗”病人：334随机“签署协议”病人：310协议治疗前即撤销注册的病人情况发现不符入选/排除标准的

9、：8主动撤回同意书的：8病情不断恶化或手术风险极大的：6其他：2即时操作成功装置成功率:(残余狭窄 0.99 同同 侧侧 小小：6（3.8%）3(2.0%)0.50 非非 同同 侧侧 小小：3（1.9%）3(2.0%)0.99 心心 肌肌 梗梗 死死 (Q 或或 NQ)4(2.5%)12(7.9%)0.04 Q-波波 心心 梗梗 0.0%2(1.3%)0.24 无无-Q 波波 心心 梗梗 4(2.5%)10(6.6%)0.10 随机病人一年间事件随机病人一年间事件事事件件 支支架架(159 pts)CEA(151 pts)p 值值 30天天后后未未发发生生非非神神经经性性死死亡亡的的MAE 9

10、（5.7）19（12.6）0.50*30天天后后未未发发生生心心梗梗或或非非神神经经性性死死亡亡的的MAE 8（5.0%）11(7.3%)0.48 *显显著著性性差差异异 非神经性死亡的病因心脏：12/21循环衰竭：4/21癌症：3/21肾衰竭：1/21多器官衰竭：1/21注册支架病人一年间事件事件事件支架注册支架注册(406 pts)死亡：死亡：41(10.1%)中风：中风：37(9.1%)同侧大同侧大13(3.2%)非同侧大非同侧大5(1.2%)同侧小同侧小16(3.9%)非同侧小非同侧小4(1.0%)心梗心梗(Q or NQ):11(2.7%)Q 波心梗波心梗2(0.5%)无无Q 波心梗

11、波心梗9(2.2%)MAE64(15.8%)注册支架病人一年间事件事件事件 注册支架注册支架(406 pts)30 天后未发生非神经天后未发生非神经性死亡的性死亡的MAE 42（10.3）31 天天 22 人发人发生非神经性死生非神经性死亡亡 30 天后未发生心梗或天后未发生心梗或非神经性死亡的非神经性死亡的MAE 38（9.4%）*显著性差异显著性差异 非神经性死亡的病因心脏：11/22癌症：5/22其他：6/22其他：肾衰竭，循环衰竭，粥样硬化性疾病，腹主动脉瘤，“非心脏或非神经性”颅神经损害（随机组）内膜剥脱术组4.6（7/151）支架置入术组0（0/159）P值0.006目标病变血管重

12、建随机组支架组由临床导致的病变血管重建：0.6（1/159）外科手术组由临床导致的病变血管重建：4.0（6/151）（p值0.06）支架注册组由临床导致的目标血管重建：0.7（3/406）随机病人30天事件与ACAS比较事件事件 支架支架(159 pts)CEA(151 pts)p 值值 未发生心梗的未发生心梗的 MAE（ACAS）6（3.8）7（4.6）0.78 与与 ACAS 相比相比 SAPPHIRE 支架支架 3.8 ACAS 2.3 0.27 SAPPHIRECEA 4.6 2.3 0.10 按照按照ACAS研究中对研究中对MAE的定义这个的定义这个30天结果在天结果在MAE方面与方

13、面与ACAS研究具有可比性研究具有可比性,结果无显著性差异结果无显著性差异 结论使用远端保护装置的支架介入术不次于内膜剥脱术在1年的观察点时使用远端保护装置的支架介入术具有更高的无事件生存率使用远端保护装置的支架介入术在心梗、同侧大中风、颅神经损害发生率方面显著低于内膜剥脱术支架介入组由临床原因导致的病损血管重建率更低用ACAS研究中对严重不良事件的定义,本研究30天时的研究结果与ACAS研究具有可比性Basket diameters 4.0,5.0,6.0,7.0,8.0 mm Vessel diameter range 3.0 7.5 mm Filter pore size 100 mic

14、rons Guidewire diameter 0.014”Guidewire Length 300 cm Crossing profile 3.2 3.9 Fr Capture sheath profile 5.1 Fr Guiding catheter compatibility 8 Fr Product Overview0.014”0.008”0.014”3.5 cm300 cm34 cm28 cm1.2-1.5 cmDeliveryDeploymentCapture4.6 Fr.(4,5mm)5.0 Fr.(6,7,8mm)Product OverviewNitinol Struts1

15、00 MicronsLaser Drilled HolesProduct OverviewCapture Sheath approaching basketCapture Sheath Capturing basketCapture SheathRetrieving FilterProduct OverviewBaseline,aggresive distal restenosis.Closed 6 mm Angioguard while crossing the lesionOpen AngioguardFlow through open AngioguardCarotid Stent Im

16、plantation Using the Angioguard Protection DeviceDr.Bernhard Reimers,Long axis3492.2 mShort axis1035.2 mComputerized photometric analysis of captured debris 100 m50 me200mAmorphous,acellular material rich in cholesterol clefts(x 62)Above fragment with evidence of platelets(x 80)Thrombotic material w

17、ith fibrotic tissue fragments(x 20)Qualitative,histopathologic analysis of captured debris Pathology Dept.,University of PadovaFinal stent resultNormal intracranial flow after filter removalFilter protection during carotid stentingICAEffective capture of emboliEcho-guided CAS Villa Maria Cecilia Hos

18、pitalCotignola(RA)-ItalyCrossing Profiles4 mm3.2 F5 mm3.3 F6 mm3.5 F7 mm3.7 F8 mm3.9 FNEW!The tapered transition at the tipNEW!Extra-supportTwo levels of wire support will be offered.Medium support8.25 CM32 CM3.5 CMStiff.Flexible Dr.Mathias,Dr.JaegerISES 2001,Miami Dr.Mathias,Dr.JaegerISES 2001,Miam

19、iPRECISENitinol stent systemA New Era starts.Precise:3rd generation of Selfexpandable Stent launched by CordisWith its unique properties it sets new standards in Carotid Stenting:.TIMES CHANGE Third generationof Self-expanding StentProfile7F6F 7F5F 5.5FDesign CriteriaThree Key Focus Areas Maintain S

20、.M.A.R.T.PerformanceMinimal Foreshortening,Radial strengthMultisegmented DesignImprove DeliverabilityLower ProfileFlexible Delivery SystemImprove Ease of UseStent Placement AccuracySMART SMART.018”PRECISEProfile 7F 6F/7F 5.5FGW Compatibility:.035”.018”.018”Working Length:120 cm 135 cm 135 cmOuter Sh

21、eath at stent:Blue/Opaque Clear ClearInner Shaft:Flexible Plastic Flexible Plastic Wire CoilTip Design:blunt tapered sculptedMarker Band Scheme:3 Markers 3 Markers 3 Markers Stent Diameters:6-10 mm 6-10 mm 5-10 mmStent Lengths:20,40,60,80 mm 20,30,40 mm 20,30,40 mmDesign EvolutionPreciseA new,innova

22、tive,low profile delivery system with the proven S.M.A.R.T.stent benefitsPrecisely Yours!A new,innovative Delivery systemFlexibility and ProfileA Unique Coil ConstructionNew Tip designConfidence in Precise positioningThe delivery system of the S.M.A.R.T.018 was optimised to provide support and flexi

23、bility in combination with a low profile3 transition zones Balanced support&flexibility Flexibility&ProfileLow Profile5.5F 5FExcellent flexibilityFlexibility&ProfilePrecise has got the highest flexibilityFlexibility&ProfileA Unique Coil ConstructionCoiled Stainless Steel ribbon(40 cm)Metal hypotubeN

24、ew coilInner catheter(transparent)Proximal markerA Unique Coil ConstructionAccuracy in stent placementCoiled Inner Shaft Design-improved flexibility and kink resistance-lower deployment force-excellent transfer of longitudinal forces for improved placement accuracyProprietary Coil-construction Accur

25、acy of placementStent Deployment Force30%Less Force required to deploy a PRECISE stent compared to S.M.A.R.T.018New design to track smoothly over.018”and.014”wiresNew Tip Design Soft material:Superior tracking Atraumatic crossingHighest flexibility on the market!New Tip DesignThe proven S.M.A.R.T.St

26、ent benefitsNitinol materialOne piece laser cutMicromesh GeometryMultisegmented DesignStent DesignS.M.A.R.T.PRECISEStent DesignSame fundamental S.M.A.R.T.-designNitinolOne-piece laser cut18 V-segments circumferentiallyMinimal foreshortening (8%)1 mm flare at both endsStruts were tuned to match a 5.5

27、F SDS and maintain similar radial strengthSegmentBridges“V”patternSegmented DesignSegmented design 18 circumferential repeating V patternsMicromesh geometry Bridges connect subsequent segments Bridges alternate direction Segment-independence every 2 mmStent Radial Resistive Force&Chronic Outward For

28、ce 1.771.841.631.760.480.400.490.430.00.20.40.60.81.01.21.41.61.82.0SMART 6x20Precise 6x20SMART 8x40Precise 8x40Force(N/cm)RRFCOFRRF and COF00.20.40.60.811.21.41.61.82N/cmN/cmSMARTPRECISEDynalinkBraided stentRadial Strength of different stents?ForeshorteningPeak to peak15o-20o Bend50o-60o BendStrut

29、Ends Facing Each OtherStrut Peak to Strut Valley AlignmentPeak-to-valley design:No compromise in bends!S.M.A.R.T.-designBraided designS.M.A.R.T.-design vs Braided DesignWallappositioningMicromesh-designExcellent scaffoldingMultisegmented Design Full ContourabilityStretching of arterybraided designsB

30、raided designs straighten the artery at the site of the lesion causing kinking of the artery distal from the lesionDistal KinkingBaselineBraided stentBraided design:stretching of vessel and distal kinkingBaselineS.M.A.R.T.-designBraided stentAdaptation to different diameterscontinuous wallapposition

31、Adaptation to different diameterscontinuous wallappositionPrePostAdaptation to different diameterscontinuous wallappositionpreprepostpostMultisegmented vs Braided designsLink-design vs.S.M.A.R.T.-design4 mm6.35mm8mm7 mm6.35mm8mm17 mm6.35mm8mmDiameter adaptability different designsS.M.A.R.T.-designLi

32、nk-designBraided designWhen S.M.A.R.T.Becomes PRECISE,a New World begins.PRECISE AvailabilityNNitinol,selfexpandable stent7Unconstrained stent diameter20Unconstrained stent lengthSPrecise delivery systemCCarotid indication5.5F6F5 mm6 mm7 mm8 mm9 mm10 mm20 mmN520SCN620SCN720SCN820SCN920SCN1020SC30 mmN530SCN630SCN730SCN830SCN930SCN1030SC40 mmN540SCN640SCN740SCN840SCN940SCN1040SCCORDIS愿意提供愿意提供最先进的技术、最优质的产品、最专业的服务最先进的技术、最优质的产品、最专业的服务全力支持中国介入学科的发展全力支持中国介入学科的发展成为共同成长的伙伴和成为共同成长的伙伴和市场的领先者市场的领先者