颈动脉介入治疗PPT演示课件

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,New 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CSSA的障碍,缺少真实的临床资料,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, MD,Angioguard脑保护伞的发明者顾问公司或股东:JNJ强生公司，Guidant, CadioMEMS,SAPPHIRE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)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,随机 334（310人被治疗）支架=159 CEA=151,支架注册406,外科拒绝,外科注册7,介入拒绝,研究概述（续）,随访时间：30天 6 月1 年 2 年3 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 LVEF 24 小时 and 4周)- 不稳定心绞痛 (CCS 分级 III/IV),关键入组标准（续）,- 严重肺疾病 - 对侧颈动脉闭塞- 对侧喉神经麻痹- 颈部放疗- 颈动脉内膜剥脱术后再发狭窄- 颈部颈内动脉高位病变或颈总动脉病变位于锁骨下- 严重的串联病变- 年龄大于 80岁,关键排除标准,急性或过去48小时内缺血性中风目标颈动脉完全闭塞已经计划在30天内行经皮或外科干预的颈总动脉口部病变,筛选和基线期,详细的神经学检查MRI 或CT 扫描 生活质量评价评估每一研究点的所有病人的筛选记录，是否适合颈动脉再通,随机病人人口统计学特征,* Significant Difference,随机病人人口统计学特征（续）,支架注册人口统计学特征,支架注册人口统计学特征（续）,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：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 30%)随机支架： 88.6%注册支架： 89.6%ANGIOGUARD成功率：(成功输送及回收ANGIOGUARD )随机支架： 95.6%注册支架： 91.6%,随机病人一年间事件,随机病人一年间事件,随机病人一年间事件,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,注册支架病人一年间事件,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,按照ACAS研究中对MAE的定义这个30天结果在MAE方面与ACAS研究具有可比性, 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,Product Overview,0.014”,0.008”,0.014”,3.5 cm,300 cm,34 cm,28 cm,1.2 - 1.5 cm,Delivery,Deployment,Capture,4.6 Fr. (4, 5mm)5.0 Fr. (6, 7, 8mm),Product Overview,Nitinol Struts,100 MicronsLaser Drilled Holes,Product Overview,Capture Sheath approaching basket,Capture Sheath Capturing basket,Capture Sheath,Retrieving Filter,Product Overview,Baseline, aggresive distal restenosis.,Closed 6 mm Angioguard while crossing the lesion,Open Angioguard,Flow through open Angioguard,Carotid Stent Implantation Using the Angioguard Protection DeviceDr.Bernhard Reimers,Long axis3492.2 m,Short axis1035.2 m,Computerized photometric analysis of captured debris,100 m,50 m,e,200m,Amorphous, acellular material rich in cholesterol clefts (x 62),Above fragment with evidence of platelets(x 80),Thrombotic material with fibrotic tissue fragments (x 20),Qualitative, histopathologic analysis of captured debris Pathology Dept., University of Padova,Final stent result,Normal intracranial flow after filter removal,Filter protection during carotid stenting,ICA,Effective capture of emboli,Echo-guided CAS Villa Maria Cecilia HospitalCotignola (RA) - Italy,Percutaneous procedure was effective in 240/241 patients,Technical Success Rate 99.58%,Crossing Profiles4 mm3.2 F5 mm3.3 F6 mm3.5 F7 mm3.7 F8 mm3.9 F,NEW !,The tapered transition at the tip,NEW !,Extra-support,Two levels of wire support will be offered.,Medium support,8.25 CM,32 CM,3.5 CM,Stiff . Flexible,Dr.Mathias, Dr.JaegerISES 2001, Miami,Dr.Mathias, Dr.JaegerISES 2001, Miami,PRECISE,Nitinol stent system,A 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 Stent,Profile,7F,6F 7F,5F 5.5F,Design Criteria,Three Key Focus Areas Maintain S.M.A.R.T. PerformanceMinimal Foreshortening, Radial strengthMultisegmented DesignImprove DeliverabilityLower ProfileFlexible Delivery SystemImprove Ease of UseStent Placement Accuracy,SMART SMART .018” PRECISEProfile 7F 6F/7F 5.5FGW Compatibility: .035” .018” .018”Working Length: 120 cm 135 cm 135 cmOuter Sheath 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 mm,Design Evolution,Precise,A new, innovative, low profile delivery system with the proven S.M.A.R.T. stent benefits,Precisely Yours!,A new, innovative Delivery system,Flexibility and ProfileA Unique Coil ConstructionNew Tip designConfidence in Precise positioning,The delivery system of the S.M.A.R.T. 018 was optimised to provide support and flexibility in combination with a low profile,3 transition zones,Balanced support & flexibility,Flexibility & Profile,Low Profile5.5F 5FExcellent flexibility,Flexibility & Profile,Precise has got the highest flexibility,Flexibility & Profile,A Unique Coil Construction,Coiled Stainless Steel ribbon (40 cm),Metal hypotube,New coil,Inner catheter (transparent),Proximal marker,A Unique Coil Construction,Accuracy in stent placement,Coiled Inner Shaft Design improved flexibility and kink resistance lower deployment force excellent transfer of longitudinal forces for improved placement accuracy,Proprietary Coil-construction Accuracy of placement,Stent Deployment Force,30% Less Force required to deploy a PRECISE stent compared to S.M.A.R.T. 018,New design to track smoothly over .018” and .014” wires,New Tip Design,Soft material:Superior trackingAtraumatic crossing,Highest flexibility on the market !,New Tip Design,The proven S.M.A.R.T. Stent benefits,Nitinol materialOne piece laser cutMicromesh GeometryMultisegmented Design,Stent Design,S.M.A.R.T.,PRECISE,Stent Design,Same 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 5.5F SDS and maintain similar radial strength,Segment,Bridges,“V” pattern,Segmented Design,Segmented design18 circumferential repeating V patternsMicromesh geometryBridges connect subsequent segmentsBridges alternate directionSegment-independence every 2 mm,RRF and COF,Radial Strength of different stents,?,Foreshortening,Peak to peak,15o - 20o Bend,50o - 60o Bend,Strut Ends Facing Each Other,Strut Peak to Strut Valley Alignment,Peak-to-valley design:No compromise in bends !,S.M.A.R.T.-design,Braided design,S.M.A.R.T.-design vs Braided DesignWallappositioning,Micromesh-designExcellent scaffolding,Multisegmented Design Full Contourability,Stretching of arterybraided designs,Braided designs straighten the artery at the site of the lesion causing kinking of the artery distal from the