闭环支架优势.-in service

1、1Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.Confidential information of Boston Scientific Corporation. Do not copy or distribute.闭环设计优势闭环设计优势Carotid Wallste

2、nt and FilterWire EZ System2Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.不同支架设计不同支架设计 开环设计开环设计 闭环设计闭环设计 Carotid WallstentTM PreciseTMAcculinkTM3Boston Scienti

3、fic Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.Confidential information of Boston Scientific Corporation. Do not copy or distribute.闭环单元设计闭环单元设计4Boston Scientific Confidentia

4、l - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.闭环单元设计的三大要素闭环单元设计的三大要素主要目的：通过临床数据的支持整合闭环设计的三大组成以将主要目的：通过临床数据的支持整合闭环设计的三大组成以将Carotid Wallstent区分区分于其他颈动脉支架于其他颈动脉支架StentLumen径向支撑力径向支撑力支架网孔面积支架网

5、孔面积单元结构设计单元结构设计5Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.Confidential information of Boston Scientific Corporation. Do not copy or distribute.支架网孔面积如何影响临床

6、结果支架网孔面积如何影响临床结果? ?6Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.CAS的目的的目的CAS的目的是预防卒中的目的是预防卒中的再次发生的再次发生卒中是第三大死因，且是致残卒中是第三大死因，且是致残的首要因素的首要因素. .*Data on file at

7、 BSC. 7Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.颈动脉支架的植入颈动脉支架的植入防止斑块的脱落是首要目的！防止斑块的脱落是首要目的！斑块覆盖是最重要的！斑块覆盖是最重要的！8Boston Scientific Confidential - For Intern

8、al Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.支架网孔面积支架网孔面积 不同的支架不同不同的支架不同CWS的网孔面积只有的网孔面积只有Acculink的的1/109Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Extern

9、ally Confidential information of Boston Scientific Corporation. Do not copy or distribute.闭环单元设计优势闭环单元设计优势Benefit #1 支架网孔面积支架网孔面积10Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not c

10、opy or distribute.Does Carotid Stent Design Influence Outcomes? R. M. Bersin, Catheterization and Cardiovascular Interventions 2008; 72:863866目前为止，已经完成3项有关颈动脉支架设计与临床结果的回顾性、非随机研究。Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. A retrospective analysis of 30 day ou

11、tcomes of a carotid artery stenting multicenter database consisting of 3179 consecutive patientsSPACE, a retrospective, randomized trial of carotid artery stenting versus endarterectomy in standard surgical risk patients with symptomatic carotid artery stenosesSchillinger M, Gschwendtner M, Reimers

12、B, et al. Does carotid stent cell design matter? A retrospective, nonrandomized review of a carotid artery stenting multicenter database consisting of 1,684 consecutive patientsDoes Carotid Stent Design Influence Outcomes? Bersin. Catheterization and Cardiovascular Interventions 2008; 72:863866. 11B

13、oston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007

14、;33:135-141. 目的: 明确颈动脉支架设计，尤其是支架网孔面积，对于颈动脉支架术后30天卒中、死亡或TIA的影响。 30天结果的回顾性分析 TIA，死亡, 大和小卒中(非心肌梗死) 共3179接受颈动脉支架手术的患者 4个中心 Bosiers, Deloose - Belgium Peeters, Verbis - Belgium Setacci, Donato et al. - Italy Cremonesi, Castriota - ItalyDoes Free Cell Area Influence the Outcome in Carotid Artery Stenting?

15、 Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141. 12Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.Does Free Cell Area Influence the Outcome in Carotid

16、Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141. 闭环支架定义为支架网孔面积 5.0mm2 例如Precise Rx Nitinol Stent SystemRX Acculink Carotid StentDoes Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141. Precise is a tradema

17、rk of Cordis Corporation, Acculink is a trademark of Abbott Cardiovascular Systems, Inc, and Xact is trademark of MedNova, Ltd.13Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not cop

18、y or distribute.第30天事件：闭环 vs. 开环支架设计TIA, 死亡, 大和小卒中Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141. 对于症状性患者，术后第对于症状性患者，术后第30天的主要事件发生率差异显著天的主要事件发生率差异显著开环支架设计(7.0%) VS 闭环支架设计闭环支架设计(2.2%) (p0.0001)Does Free Cell Area Influence

19、 the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141. N=3179P=0.005N=1317P0.0001N=1862P=1.014Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do

20、 not copy or distribute.Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141. 术后=(TIA, 卒中, 死亡) 直到术后30天发生 闭环 vs. 开环支架设计Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg

21、 2007;33:135-141. 对于症状性患者，手术30天以后的主要事件发生率差异显著开环支架设计(6.3%) VS 闭环支架设计闭环支架设计(1.3%) (p0.0001)N=3179P0.0001N=1317P0.0001N=1862P=1.015Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy

22、 or distribute. 患者评估 由独立神经病学医师进行神经学上的 局限性 回顾性的研究 非随机设计可能导致在选择时会因特定病变类型有所偏向 注册数据受制于自我审计 技术复杂性没有评估，结果没有经过风险校正 有必要进行前瞻性的随机研究来比较不同支架网孔面积以得到最终结论Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141. Does Free Cell Area Influence the

23、Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141. 16Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.总结总结 四个中心的30天结果回顾性

24、分析 N=3179 CAS patients 对于症状性患者，术后第30天的主要事件发生率差异显著，开环支架设计(7.0%) VS 闭环支架设计(2.2%) (p0.0001) 对于症状性患者，手术30天以后的主要事件发生率差异显著，开环支架设计(6.3%) VS 闭环支架设计(1.3%) (p0.0001)Does Free Cell Area Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141. Does Free Cell Are

25、a Influence the Outcome in Carotid Artery Stenting? Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135-141. 17Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.Co

26、nfidential information of Boston Scientific Corporation. Do not copy or distribute.单元结构设计如何影响临床结果单元结构设计如何影响临床结果? ?18Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribu

27、te.闭环单元设计优势闭环单元设计优势Benefit #2-Benefit #2-更光滑平整的内腔更光滑平整的内腔当使用闭环设计支架时，血栓保护装置挂在支架上的发生率更低当使用闭环设计支架时，血栓保护装置挂在支架上的发生率更低19Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribut

28、e.闭环与开环支架设计的腔内影像闭环与开环支架设计的腔内影像20Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.支架单元设计如何影响器械的交换支架单元设计如何影响器械的交换输送鞘的回撤输送鞘的回撤复杂解剖结构会增加回撤的困难闭环单元设计的支架显示出优势首选回收鞘管设计: 同

29、轴系统 软头快速交换系统Sharp Entry AngleSharp Exit AngleDr. S.Myla BSC Carotid Symposium TCT 200521Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.单元结构设计的体内比较单元结构设计的体内比较Cou

30、rtesy of Dr. Hoffmann开环支架开环支架Acculink闭环支架闭环支架Carotid Wallstent一个病人，两种支架，两种截然不同的结果！一个病人，两种支架，两种截然不同的结果！22Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.输送装置回收对比：

31、开环输送装置回收对比：开环 vs. 闭环单元支架闭环单元支架 Dr. Myla在闭环支架中，更容易回收球囊导管、支架输送系统和血栓保护装置，在闭环支架中，更容易回收球囊导管、支架输送系统和血栓保护装置，挂在支架连接杆上的发生率更低挂在支架连接杆上的发生率更低23Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not c

32、opy or distribute.Confidential information of Boston Scientific Corporation. Do not copy or distribute.24Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.闭环单元设计优势

33、闭环单元设计优势Benefit #3 径向支撑力径向支撑力当使用闭环设计支架时，术后低血压的发生率更低当使用闭环设计支架时，术后低血压的发生率更低! !25Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.颈动脉分叉的解剖结构颈动脉分叉的解剖结构颈内动脉具有压力感受器颈内动脉

34、具有压力感受器压力感受器的主要作用是维持动脉血压，以保证组织得到适量的血液供应压力感受器的反应直接与压力范围相关（外部或内部压力）。压力增大会引起压力感受器反射性的降低血压，造成低血压。26Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.径向支撑力与低血压的关系径向支撑力与

35、低血压的关系支架的释放产生向外的径向支撑力支架的释放产生向外的径向支撑力，对颈动脉产生压迫，对颈动脉产生压迫压力感受器感受到压力的变化，并刺激迷走中枢，反射性的引压力感受器感受到压力的变化，并刺激迷走中枢，反射性的引起血管扩张起血管扩张 预扩张预扩张 (PTA)产生对颈动脉的产生对颈动脉的压迫压迫低血压低血压术后术后+24 hrs低血压低血压术中术中*Baroreceptors quickly respond to small changes in blood pressure. They fail to respond to higher pressure levels after one

36、or more days. Treatment of hypotension may cause complications for hypertensive patients. Katzen presentation CIRSE 2006.慢性慢性*急性急性回撤球囊回撤球囊即可解决低血压问题即可解决低血压问题药物控制药物控制27Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Bost

37、on Scientific Corporation. Do not copy or distribute.径向支撑力与抗血管回缩能力的区别径向支撑力与抗血管回缩能力的区别“支架自我向外扩张的能力支架自我向外扩张的能力”“支架抵抗管壁回缩的能力支架抵抗管壁回缩的能力”StentLumenLumenStent28Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Confidential information of Boston Scientific Corporation. Do not copy or distribute.不同类型支架的径向支撑力不同类型支架的径向支撑力*Source: Boston Scientific Stent Test Report #90155656钴铬合金编织支架钴铬合金编织支架镍钛合金雕刻支架镍钛合金雕刻支架Carotid WallstentNexStentExponentXactAcculinkProtgPrecise29Boston Sc