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1、,血管远端保护装置 大坪医院心血管内科 王旭开,The system is CE marked for central and peripheral vascular applications,微血栓-罪犯,由动脉粥样硬化病变或其它来源的颗粒碎屑脱落至血管床的远端，可以引起微血管床的阻塞而发生微血栓栓塞当粥样斑块被球囊挤压后会有许多脂质样物质或斑块的碎裂物质脱落下来进入血管远端的毛细血管床引起微栓塞,The system is CE marked for central and peripheral vascular applications,微血管阻塞,粥样斑块,栓子,微血管堵塞,微血管痉孪
2、或水肿,血小板聚集,15-100um直径的微粒可引起豚鼠心肌心功能异常，多次使用直径um微粒致多次微梗塞比同量的一次心肌梗塞后心功能异常更严重,Hori M,et.al.Am J Physiol 1986;250:H509-18.,The system is CE marked for central and peripheral vascular applications,Embolization,破裂的纤维帽,粥样斑块,大脂核,血栓,不稳定斑块的纤维帽破裂，释放大量脂核中的脂质，总量可达毫升残余部分是高凝物质，很快形成血栓This is likely an ongoing process
3、of rupturing and healing,resulting in progression of CAD and unstable angina,or the thrombus may occlude the vessel resulting in acute MI.,ACS Vulnerable Plaque,The system is CE marked for central and peripheral vascular applications,狗心肌模型发现：15100m颗粒可引起局部心肌收缩功能异常,少量的大颗粒可以完全阻塞小血管大量的小颗粒也可以引起微梗死与同样大小的单
4、一梗死相比，由多个微颗粒引起的多发性微梗死所导致的灌注收缩不匹配更明显,The system is CE marked for central and peripheral vascular applications,SAFE研究,发现103例患者（105处病变）91收集到颗粒2.组织学检查100可见纤维蛋白和坏死组织80.2可见泡沫细胞28.5可见胆固醇,The system is CE marked for central and peripheral vascular applications,血管粥样斑块,Effeney DJ,Stoney RJ.Wylies Atlas of Vas
5、cular Surgery:Extracranial Cerebrovascular Disease;1992,The system is CE marked for central and peripheral vascular applications,微血管阻塞 Evidence Points to Microembolization,慢血流无再流现象是微血栓的结果,是损害心肌灌注导致心肌坏死的罪犯原因远端微血栓的发生率远比以前估计的要高微血栓发生后的临床后果十分严重:难治的心衰、心源性猝死,The system is CE marked for central and peripher
6、al vascular applications,检测微血栓的技术手段：,心脏磁共振显像（MRI）微栓塞的证据：MRI能够显示心内膜下微血管阻塞，且证明微血管阻塞与预后相关超声造影方法：尽管冠脉造影证实TIMI血流正常，但是超声造影发现有25的患者仍然存在心肌灌注受损单光子断层显像（SPECT）：对患者施行冠状动脉腔内旋磨术治疗时，尽管患者术后无心肌酶学的改变，SPECT检查证实术中可出现心肌灌注受损,The system is CE marked for central and peripheral vascular applications,微栓塞的临床证据 By MRI,磁共振可显示心内
7、膜下的微血栓无事件存活率,5,10,15,20,25,Months,100,80,60,40,20,0,Event-Free Survival,No Microvascular Obstruction,n=33,Microvascular Obstruction,n=11,P 0.01,Wu K,et.al.Circulation.1998;97:765-772,The system is CE marked for central and peripheral vascular applications,微栓塞的临床证据 By SPECT,SPECT 能显示心肌灌注缺损，此时可能无心肌酶学的
8、升高血小板糖蛋白b/a受体拮抗剂阿昔单抗(abciximab)治疗有效,提示血小板血栓栓塞参与了这一病理过程,Koch K-C,et.al.JACC.1999;33:998-1004.,The system is CE marked for central and peripheral vascular applications,回顾分析:成功完成PCI的 1065 病例(1693 罪犯病变)成功的定义：残余狭窄 50%,无院内 NSTMI,死亡,急诊 CABG“无并发症”的定义:727 名病人(1082 病变)无与操作有关的并发症：含血管远端栓塞的证据,TIMI 3,no reflow,EC
9、G 显示再缺血,再闭塞,急诊 IABP 介入，或再次PCI,微栓塞的临床证据 CK-MB Elevation,Hong,MK et.al.Circulation;100:2400-2405,1999.,The system is CE marked for central and peripheral vascular applications,Microinfarcts malignant ventricular arrhythmiasDistal Embolization microcirculation abnormality/outflow obstruction thrombotic
10、 occlusion/sudden deathNo cause and effect relationship,1 Yr.Mortality(%),1 Yr.Mortality(%),全部病例,无并发症的病例,Hong,MK et.al.Circulation;100:2400-2405,1999.,4.8%,6.5%,11.7%,10.7%,5.5%,2.4%,微栓塞的临床证据 CK-MB Elevation,The system is CE marked for central and peripheral vascular applications,CK-MB升高程度越明显，病人预后越差
11、，死亡率越高,目前认为CK-MB升高远期死亡率增加的原因可能为 微梗死引起恶性心律失常 远端栓塞导致微循环异常血栓阻塞/猝死,The system is CE marked for central and peripheral vascular applications,微血栓的来源?,自发性：斑块破裂外源性：介入过程中机械损伤 临床容易发生微栓塞的患者：急性冠脉综合征患者大隐静脉旁路移植血管（SVG）介入颈动脉球囊成形和支架植入术肾动脉支架植入术其他介入，尤其是斑块旋磨和旋切时,The system is CE marked for central and peripheral vascul
12、ar applications,ACS 病理生理,ActiveFissure,Resealed Fissure,Mural Thrombus,Occlusive Thrombus,Topol EJ.Current and Emerging Anti-Thrombotic Therapies for Acute Coronary Syndromes.J Inv Cardiol 1998;10:2D-7D.,The system is CE marked for central and peripheral vascular applications,SpontaneousEvent,Thromb
13、olysis,PTCA,Stenting,易发生远端微血栓的操作,越少,越多,The system is CE marked for central and peripheral vascular applications,心肌救治链,Presented by W.ONeil at Interventional Cardiology Fellows Course,San Jose,2001,The system is CE marked for central and peripheral vascular applications,0 无 1 少量 2 慢充盈 3 正常,TIMI 有局限性、
14、主观性,The system is CE marked for central and peripheral vascular applications,TIMI血流帧数技术法 Corrected TIMI Frame Count,定义:在梗死相关动脉造影剂首先到达冠状动脉远端所需要的电影帧数。CTFC 15 to 27Mean=21.0 frames,The system is CE marked for central and peripheral vascular applications,TIMI血流帧数技术法(CTFC),识别开始计分的第一帧画面:主干血管的部分充盈血管边缘现象染色在
15、不断深入运动中 所采用的远端路标:LAD:达到心脏远端分叉LCX:最远分叉,包含病变血管的主要分叉RCA:后侧降支的第一分叉,The system is CE marked for central and peripheral vascular applications,Normal Flow in theAbsence of MI:21.0 3.1 Frames,0,5,10,15,21,First FrameDefinition,Last FrameDefinition,Frame 0:DyeTouches Oneor No Borders,Frame 21:Dye FirstEnters
16、Landmark,Frame 1:DyeTouches BothBorders&MovesForward,Corrected TIMI Frame Count,Gibson CM.Circulation 1996;93:879-888.,The system is CE marked for central and peripheral vascular applications,这种方法也不能完全反映出心肌组织水平的实际灌注情况，而心肌组织的灌注主要取决于微血管水平小冠脉和毛细血管,MYOCARDIUM BLUSH,The system is CE marked for central an
17、d peripheral vascular applications,心肌染色,作为测定心肌灌注的指标心肌染色可以评价远端微血管的造影剂充盈。随造影剂注射入冠状动脉，远端毛细血管充盈会晚些，表现为心外膜血管间心肌内的造影剂染色观察心肌染色要求采集时间应足够长。,The system is CE marked for central and peripheral vascular applications,心肌染色,TIMI Flow Grade assesses flow in the large epicardial coronary vessels,心肌染色的分级越低，病死率越高，与患者的
18、预后差。,Myocardial blush assesses contrast filling in these distal microvessels as ameasure of myocardial perfusion.,The system is CE marked for central and peripheral vascular applications,心肌染色评定的分级为：,心肌染色O级：无心肌染色或心肌不显影。心肌染色1级：有心肌染色，但是造影剂不排空（在下一次注射时仍有造影剂残留）。心肌染色2级：心肌染色清除缓慢即在3个心动周期里心肌染色清除很少或根本没有清除。心肌染色
19、3级：心肌染色很快消除，在三个心动周期后仅有很少存留。,The system is CE marked for central and peripheral vascular applications,心肌染色评定分级与患者病死率,心染色分级 0 1 2 3 发生率Stone.et al 30 4228Vant Hof.Et al 30 5119 病死率Stone.Et al 2213 6Vant Hof.Et al 23 6 3,The system is CE marked for central and peripheral vascular applications,血管远端保护装置
20、分类,球囊堵塞抽吸系统 AVE MEDRONIC guardwire导管连接滤网 BOSTON filterwire CORDIS angioguard,The system is CE marked for central and peripheral vascular applications,The GuardWire Plus System,GuardWire Plus,Inflation System:MicroSeal Adapter&EZ Flator,Export Aspiration Catheter,The system is CE marked for central a
21、nd peripheral vascular applications,保护 AMI Intervention,Presented by E.Grube,MD,at Interventional Cardiology 2000:An International Symposium,Aspen,CO,March 2000,NOTE:The PercuSurge GuardWire System is not approved for sale in the United States.,The system is CE marked for central and peripheral vasc
22、ular applications,保护 AMI Intervention Zurich Single Center Experience,TIMI Flow Grade(pre)n%03978I1020II22III00,TIMI Flow Grade(post)n%000I00II24III4996,Angiographic Results:,Amann FW,Sutsch G.Annual Meeting of the Swiss Society of Cardiology,The system is CE marked for central and peripheral vascul
23、ar applications,Amann FW,Sutsch G.TCT 2000,保护 AMI Intervention Zurich Single Center Experience,CTFC32.9Blush 318.8%,CTFC23.4Blush 354.5%,Note:CTFC of 21 denotes normal flow,无保护,有保护,Comparison of PercuSurge to historical trial data-TIMI 4,10A,10B,14,&LIMIT Trials,The system is CE marked for central a
24、nd peripheral vascular applications,保护 AMI Intervention Zurich Single Center Experience,78岁的男性,3 1/2 hrs 的胸痛发作,Crossingwith GuardWire,Finalresult,Thrombus,Distalocclusion,Stent,Distalprotection,Amann FW,Sutsch G.Annual Meeting of the Swiss Society of Cardiology,The system is CE marked for central an
25、d peripheral vascular applications,保护 AMI Intervention Zurich Single Center Experience,Amann FW,Sutsch G.UH Zurich,The system is CE marked for central and peripheral vascular applications,保护 AMI Intervention Zurich Single Center Experience,Amann FW,Sutsch G.Annual Meeting of the Swiss Society of Car
26、diology,The system is CE marked for central and peripheral vascular applications,保护颈动脉操作 1,A,B,The system is CE marked for central and peripheral vascular applications,保护颈动脉操作 2,C,2023/5/25,The system is CE marked for central and peripheral vascular applications,保护颈动脉操作 3,2023/5/25,D,The system is C
27、E marked for central and peripheral vascular applications,保护颈动脉操作 4,E,The system is CE marked for central and peripheral vascular applications,AVE MEDRONIC guardwire系统的优点：,可完全控制微循环，不但可以收集所有的大小颗粒，而且还可以抽出一些神经体液物质头端较小，尤其适合于狭窄程度较重的自身冠状动脉病变收集脱落物质的量不受限,The system is CE marked for central and peripheral va
28、scular applications,由于球囊堵塞引起缺血，因此不适合于能够引起大面积缺血的病变和高危险的患者制造和技术缺点为：近端或主干病变有一定的难度对于无前向血流的介入治疗病例有一定难度空心导丝的操作性能和支撑力不像一般的0.014英寸(1英寸2.54厘米)导引钢丝不能保护血管封闭球囊远端的病变,AVE MEDRONIC guardwire缺点为:,The system is CE marked for central and peripheral vascular applications,两类远端保护装置特点比较,球囊阻塞保护装置血管内的血流需要暂时完全阻断介入干预过程中栓子和斑块
29、碎片在血管内需要一个吸引导管将栓子碎片吸出,滤网保护装置滤网张开时保持血流灌注当滤网收紧可以将栓子和斑块碎片抽出在回抽过程中，小的碎片仍然可能穿过滤网或经滤网周围漏出,The system is CE marked for central and peripheral vascular applications,跨过病变（SVG）,导丝跨过病变When torquing the wire,manipulations of the wire should be performed distal to the gold marker band球囊距离病变至少2厘米There must be eno
30、ugh space to accommodate the PTCA/stent balloon catheter tip,2cm 病变到球囊的距离,The system is CE marked for central and peripheral vascular applications,处理病变（SVG）,一旦确定全部膨胀起来,将适配器上的灰色旋钮拨至 CLOSE MICROSEAL移出适配器上的导丝送入 PTCA/stent 导管开始介入操作 GuardWire 会防止远端栓塞移出 PTCA/stent 导管注意:导丝的稳定十分重要,The system is CE marked fo
31、r central and peripheral vascular applications,吸取碎屑（SVG）,送入 Export 导管到闭塞球囊的最远处;在(1-2 sec)的停顿中并缓慢的回撤导管的过程中不断抽吸;旋转取下抽满的注射器,换上另一个继续抽吸.,The system is CE marked for central and peripheral vascular applications,血栓（SVG）,The system is CE marked for central and peripheral vascular applications,回抽球囊（SVG）,球囊一旦
32、不再贴壁,立即就有血流通过;一旦球囊完全抽空,马上拨EZ Flator 把柄回到中间的位置将适配器上的灰色旋钮拨至CLOSE MICROSEAL,取下适配器,移去导丝.,The system is CE marked for central and peripheral vascular applications,阻断血流的时间,使用 GuardWire 须仔细评估病变和谋划好相应的救急步骤让团队的每一个成员配合默契全部相关器材准备就绪在插入治疗导管前一定要充起封闭球囊将 GuardWire 装入适配器,以便抽吸一结束就立即回抽球囊,The system is CE marked for ce
33、ntral and peripheral vascular applications,注意事项 一,如果有折断或折痕,不能使用与球囊导管一样,不要朝同一方向连续旋转两圈以上在导管交换时,一定冲洗内腔,或用湿肝素盐水纱布擦导丝湿肝素盐水纱布擦导丝要轻柔球囊充起后不能再调整导丝的位置,The system is CE marked for central and peripheral vascular applications,注意事项 二,在球囊充起前可推注显影剂,一旦球囊充起,将不能对照的显影如果病变非常靠近主干,在抽吸前不要推注造影剂,以免把碎屑带入主动脉球囊充起的过程中,可轻柔地注入少量造
34、影剂到血管里,一旦球囊全部充起,造影剂就会留在那里作为路标选择一个能够覆盖病变的支架来全部压迫病变血管,稍微长些的支架也可以,The system is CE marked for central and peripheral vascular applications,注意事项 三,在没有病变的血管段充起球囊使带有标记部分的导丝离病变3厘米在交换导管时一定要固定好导丝,充起的球囊移动会撕破血管,The system is CE marked for central and peripheral vascular applications,Landing Zone,理想的附着区,不适当的附着区
35、,The system is CE marked for central and peripheral vascular applications,LEVEL I病变的形态单病变单一的向心性无血栓病变的位置单血管小的弯曲无钙化(5mm)有理想的球囊附着区(正常血管段 20mm)TIMI Flow:3 EF 40%,选择病人 一,The system is CE marked for central and peripheral vascular applications,LEVEL II病变形态多个病变螺悬性的(10-20cm)偏心性的有部分血栓病变位置单一血管或多病变部位中等弯曲近端病变(距
36、主干开口5mm)球囊附着区=20mmTIMI Flow:2-3Ejection Fraction:25%,选择病人 二,The system is CE marked for central and peripheral vascular applications,LEVEL III病变形态多个病变弥漫性病变偏心性明确的血栓病变位置单一血管多病变中等到严重的弯曲近端病变(距离开口 5mm 以内)球囊附着区 约 20mm 距离远端连接处仅存的供血血管TIMI Flow:0-3Ejection Fraction:25%,选择病人 三,The system is CE marked for cent
37、ral and peripheral vascular applications,使用前必须充分评估是否需要该系统?直接支架或先处理血栓?支架前端是否有足够的预留区域?万一出现急性心脏事件怎么办?There is no need to rush!,临床评估,The system is CE marked for central and peripheral vascular applications,预测临床结果 50%疗效:?SAFER 结果:42%的住院病人的住院天数 16.5%降到 9.6%56.5%病人的死亡率从 2.3%降低 1.0%41.5%病人的(QMI/NQMI)从 14.7%降低到8.6%,效/价 评估,The system is CE marked for central and peripheral vascular applications,理想的远端保护装置应具备,能完全收集栓子（小的碎屑、栓子等）保护过程中能保证病变远端灌注保护过程中能直接进行血管造影和支架术，不影响显影和位置的判定临床研究证实安全、有效成本效价比适宜目前没有一种器械能够彻底防止栓子碎屑,大量小碎屑可能和少量大的碎片同样有害。,The system is CE marked for central and peripheral vascular applications,谢谢！,
