頸動(dòng)脈支架置入術(shù)

1、頸動(dòng)脈支架置入術(shù),SAPPHIRE 研究,CEA高?；颊弑Ｗo(hù)裝置下支架置入與血管成形試驗(yàn) （stenting and angioplasty with protection in patient at high rish for endarterectomy, SAPPHIRE） 第一項(xiàng)在有癥狀或無(wú)癥狀頸動(dòng)脈狹窄患者中比較CAS和CEA療效的多中心隨機(jī)對(duì)照研究,介入器材,ANGIOGUARD血栓保護(hù)裝置,Cordis PRECISE支

2、架,入選病例被隨機(jī)分入使用保護(hù)裝置的支架介入術(shù)組(n=159)和內(nèi)膜切除術(shù)組(n=151),對(duì)于風(fēng)險(xiǎn)過(guò)高的病人，由介入科醫(yī)生、血管外科醫(yī)生和神經(jīng)科醫(yī)生組成的醫(yī)生小組共同決定進(jìn)入注冊(cè)組,CONSENSUS一致同意,RANDOMIZED, PROSPECTIVE隨機(jī)，前瞻性310 (12 month)Stenting支架組=159 / CEA=151,STENTREGISTRY支架注冊(cè)407,SURGICAL REFUSAL外

3、科拒絕,SURGICALREGISTRY外科注冊(cè)7,INTERVENTIONALREFUSAL介入拒絕,,,,醫(yī)生小組：神經(jīng)科醫(yī)生，外科醫(yī)生，介入科醫(yī)生,The SAPPHIRE Trial,SAPPHIRE (high-risk patients) 30 days and 12 months results,SAPPHIRE (high-risk patients) 30 days and 12 month results,

4、“Stented patients are now 12 months out from treatment, and their MAE rate continue to be as good as, and in many ways better than, those for the surgically treated group.”接受治療12個(gè)月后，支架組病人不良事件的發(fā)生率相當(dāng)于，甚至在很多方面，優(yōu)于手術(shù)治療組。,12

5、 month Results: CAS vs. CEA,Overall MAE rate總體主要不良事件發(fā)生率11.9% vs. 19.9% : ~ difference 顯著差異, p = 0.06Death rate 死亡率6.9% vs. 12.6%: ~ double number of patients died in the CEA arm 外科組死亡人數(shù)比支架組多一倍Stroke rate中風(fēng)發(fā)

6、生率 5.7% vs. 7.3%:~ 30% more patients experienced a stroke in the CEA arm 外科組至少發(fā)生一次中風(fēng)的病人數(shù)比支架組多30%Major Ipsilateral Stroke rate主要同側(cè)大中風(fēng)發(fā)生率 0.0% vs. 3.3% ~ was significant higher in CEA 外科組顯著高于支架組，p = 0.03MI

7、 (Q or non Q) rate 心梗發(fā)生率2.5% vs. 7.9%:~ patients got > 3 times more MI in the CEA arm 外科組發(fā)生心梗的病人數(shù)比支架組多三倍以上Outcome of cranial nerve injury (30 days) 30天內(nèi)顱神經(jīng)損傷的發(fā)生率 0.0% vs. 5.3%:~ was significant for CEA arm

8、外科組顯著高于支架組，p < 0.01,結(jié) 論,,ISC 2010 -CREST,CREST設(shè)計(jì),前瞻、多中心、隨機(jī)對(duì)照試驗(yàn)，盲法判定比較對(duì)于癥狀性和無(wú)癥狀性頸動(dòng)脈狹窄患者是CEA還是CAS更好每個(gè)中心團(tuán)隊(duì)包括神經(jīng)科醫(yī)生、介入醫(yī)生、外科醫(yī)生和研究協(xié)調(diào)員,9,患者分組和基本情況,10,主要終點(diǎn)（卒中、心梗、圍手術(shù)期死亡加同側(cè)卒中）,HR=1.1195%CI 0.81-1.51P=0.51,主要終點(diǎn):圍手術(shù)期事件（死亡、卒

9、中、心梗）,HR=1.1895%CI 0.82-1.68P=0.38,圍手術(shù)期卒中,卒中HR=1.7995% CI 1.14-2.82P=0.01,心梗HR=1.3595% CI 0.54-3.36P=0.52,圍手術(shù)期顱神經(jīng)麻痹,HR=0.0795% CI 0.02-0.18P<0.0001,同側(cè)卒中,HR=0.9495% CI 0.50-1.76P=0.85,結(jié)論,CEA和CAS有相同的凈預(yù)后，盡管各自

10、風(fēng)險(xiǎn)不同，但是CAS有較低的心梗發(fā)生，CEA有較低的卒中風(fēng)險(xiǎn)年輕患者CAS獲益多，年長(zhǎng)患者CEA獲益多有經(jīng)驗(yàn)的中心CEA和CAS顯示更低的圍手術(shù)期并發(fā)癥，有更杰出的預(yù)后未來(lái)，CEA和CAS是預(yù)防卒中有用的工具,適應(yīng)癥,無(wú)癥狀血管狹窄程度大于70％，有癥狀(TIA 或中風(fēng)發(fā)作)血管狹窄程度大于50％狹窄程度小于50％，但有潰瘍性斑塊形成某些肌纖維發(fā)育不良者，大動(dòng)脈炎穩(wěn)定期有局 限性狹窄放療術(shù)后或內(nèi)膜剝脫術(shù)后、支架

11、術(shù)后再狹窄由于頸部腫瘤壓迫等受壓而導(dǎo)致的狹窄急性動(dòng)脈溶栓后殘余狹窄,禁忌癥,3個(gè)月內(nèi)有顱內(nèi)出血，2周內(nèi)有新鮮腦梗塞 不能控制的高血壓 對(duì)肝素、阿司匹林或其他抗血小板類藥物有禁忌者 對(duì)造影劑過(guò)敏者 頸內(nèi)動(dòng)脈完全閉塞 伴有顱內(nèi)動(dòng)脈瘤，并且不能提前或同時(shí)處理者 在30天以后預(yù)計(jì)有其他部位外科手術(shù)者 2周內(nèi)曾發(fā)生心肌梗塞 有嚴(yán)重心、肝、腎疾病,術(shù)前準(zhǔn)備,術(shù)前6小時(shí)禁食水術(shù)前6小時(shí)之內(nèi)碘過(guò)敏試驗(yàn) 雙側(cè)腹股溝區(qū)備皮 術(shù)前3

12、~5天口服抗血小板藥物：氯吡咯雷75mg+阿司匹林100mg頸部血管超聲，TCD評(píng)價(jià)局部腦血流評(píng)價(jià)(核磁共振灌注、PET、CT灌注或SPECT其中一項(xiàng)或以上)全腦血管造影或CTA、MRA,,,狹窄程度的評(píng)價(jià),參照NASCET標(biāo)準(zhǔn) 狹窄率% =（1 - A/B）× 100 狹窄程度 輕度（0%-29%） 中度（30%-69%） 重度（70%-99%）,操作方法,經(jīng)股動(dòng)脈采用Seldinger技術(shù)穿刺

13、，一般放置8F導(dǎo)管鞘，導(dǎo)管鞘連接加壓鹽水持續(xù)滴注沖洗肝素（50–100 U/kg)導(dǎo)引導(dǎo)管后面接Y閥或止血閥并與加壓鹽水連接，在0.035”泥鰍導(dǎo)絲小心導(dǎo)引下放在患側(cè)頸總動(dòng)脈，頭端位置距離狹窄約3~5cm。過(guò)度迂曲的頸總動(dòng)脈可以使用交換導(dǎo)絲將導(dǎo)引導(dǎo)管交換到位 通過(guò)導(dǎo)引導(dǎo)管造影測(cè)量狹窄長(zhǎng)度和直徑選擇合適支架，并行患側(cè)狹窄遠(yuǎn)端顱內(nèi)動(dòng)脈造影以備支架術(shù)后對(duì)照,操作方法,通過(guò)導(dǎo)引導(dǎo)管將保護(hù)裝置小心穿過(guò)狹窄并將其釋放在狹窄遠(yuǎn)端4~5cm位置，

14、撤出保護(hù)裝置外套。支架置入前靜脈給予阿托品0.5mg以防心動(dòng)過(guò)緩及低血壓 置入支架，造影檢查支架術(shù)后殘余狹窄管徑，酌情作支架內(nèi)后擴(kuò)如果狹窄特別嚴(yán)重，或血管彎曲影響保護(hù)傘的安全通過(guò)，可選擇合適的球囊行預(yù)擴(kuò)最后撤出保護(hù)裝置，行頸部以及患側(cè)顱內(nèi)動(dòng)脈造影與術(shù)前對(duì)比 Aguard Deploy Mov Pic.mpg,腦保護(hù)裝置,,,,,,腦保護(hù)裝置,支架類型,球擴(kuò)式支架Palmaz Stent (Cordis)

15、自膨式支架Carotid Wallstent (Boston Scientific)PRECISE (Cordis)Protégé (ev3)Acculink (Abbott）,自膨式支架,雕刻支架 編織支架,編織支架,優(yōu)點(diǎn)支撐力更大,不易塌陷柔韌性更強(qiáng)，表面光滑，易于球囊通過(guò)網(wǎng)孔密集，限制斑塊脫落可重新定位、再次釋放,編織支架,不足短縮、不易精確定位拉伸頸動(dòng)脈、上端扭曲、

16、成角凹凸不平處貼壁欠佳,雕刻支架,優(yōu)點(diǎn)順應(yīng)性好，適應(yīng)不同形狀而不造成血管強(qiáng)直貼壁性好，不易造成死腔基本無(wú)縮短，定位和選擇長(zhǎng)度較精確不足后擴(kuò)時(shí)有連接點(diǎn)斷裂的風(fēng)險(xiǎn),支架選擇,支架直徑 (完全張開(kāi)) 必須至少比最大的目 標(biāo)血管大 1 mm 目標(biāo)血管：CCA支架長(zhǎng)度：兩端至少超過(guò)狹窄 0.5～1 cm ， 并覆蓋“健康” 動(dòng)脈如果頸動(dòng)脈狹窄累及分叉處，則支架至少 要放 1 cm 在頸總動(dòng)脈,支架選擇,頸

17、動(dòng)脈迂曲不明顯及狹窄邊緣較光整時(shí)，選用Wallstent或雕刻支架均可頸動(dòng)脈迂曲較明顯時(shí)，雕刻支架的柔順性和貼壁性較好高危斑塊（軟斑塊）宜選用Wallstent如果必須處理頸外動(dòng)脈病變，則只能選用Wallstent，以便在Wallstent的網(wǎng)眼中進(jìn)行擴(kuò)張,頸動(dòng)脈支架置入術(shù),頸動(dòng)脈支架置入術(shù),,,,,External Carotid Artery,Internal Carotid Artery,Common Carotid Art

18、ery,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,,,Terumo guidewire0.035”100cm,Headhunter5F Tempo200cm,INTRODUCE GUIDEWIRE AND INTRODUCER SHEATH,External Carotid Artery,Internal Carotid Arter

19、y,Common Carotid Artery,,,,,,,Terumo guidewire0.035”100cm,Headhunter5F Tempo200cm,INTRODUCE GUIDEWIRE AND INTRODUCER SHEATH,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,,,,,,,,SELECTIVE CATH

20、ETHETERISATION OF ECA,Terumo guidewire0.035”100cm,Headhunter5F Tempo200cm,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,,,,,,,,Headhunter5F Tempo200cm,EXCHANGEGUIDEWIRE,Terumo guidewire0.

21、035”100cm,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,,,Headhunter5F Tempo200cm,EXCHANGEGUIDEWIRE,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,,,,,,,,Headhunter5F T

22、empo200cm,EXCHANGEGUIDEWIRE,Amplatz Emerald0.035”260cm,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,,,,,,Amplatz Emerald0.035”260cm,EXCHANGEINTRODUCER SHEATH,External Carotid Artery,Intern

23、al Carotid Artery,Common Carotid Artery,,,,,,,Amplatz Emerald0.035”260cm,Brite Tip Sheath7F80cm,EXCHANGEINTRODUCER SHEATH,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,Brite Tip Sheath7F80

24、cm,REMOVE GUIDEWIRE,Carotid Artery Disease :Carotid Angioplasty - ProcedureHints,At this stage :Never cross the lesion in the ICA,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,Brite Tip Sheat

25、h7F80cm,INTRODUCE PROTECTION DEVICE,,,,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,Angioguard0.014”300cm,Brite Tip Sheath7F80cm,INTRODUCE PROTECTION DEVICE,Angioguard Device :Delivery

26、Sheath Covering Filter,,,,,,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,Brite Tip Sheath7F80cm,CROSS LESION WITH PROTECTION DEVICE,Angioguard0.014”300cm,,,,,,,,,,External Carotid Artery,In

27、ternal Carotid Artery,Common Carotid Artery,Brite Tip Sheath7F80cm,CROSS LESION WITH PROTECTION DEVICE,Angioguard0.014”300cm,,,,,,,,,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,DEPLOYMENT

28、 PROTECTION DEVICE,Brite Tip Sheath7F80cm,Angioguard0.014”300cm,Angioguard Device :Filter Deployed,Carotid Artery Disease :Carotid Angioplasty - ProcedureHints,Hold the protection device always in the screen, NOT

29、inside the brain ( bleedings ),,,,,,,,,,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,STENT DEPLOYMENT,Smart Carotid stent7-8mm30-40mm,Brite Tip Sheath7F80cm,Angioguard0.014”300cm,,,,,,,,,,

30、,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,Brite Tip Sheath7F80cm,Smart Carotid stent7-8mm30-40mm,STENT DEPLOYMENT,Angioguard0.014”300cm,,,,,,,,,,,External Carotid Artery,Internal Carot

31、id Artery,Common Carotid Artery,Brite Tip Sheath7F80cm,Smart Carotid stent7-8mm30-40mm,ANGIOGRAPHICCONTROL,Angioguard0.014”300cm,,,,,,,,,,,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,Bri

32、te Tip Sheath7F80cm,Smart Carotid stent7-8mm30-40mm,ANGIOGRAPHICCONTROL,Angioguard0.014”300cm,,,,,,,,,,,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,Savvy balloon5-6mm30-40mm,Brite Tip

33、Sheath7F80cm,Smart Carotid stent7-8mm30-40mm,POSTDILATATION,Angioguard0.014”300cm,,,,,,,,,,,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,Brite Tip Sheath7F80cm,Smart Carotid stent7-8mm

34、30-40mm,POSTDILATATION,Angioguard0.014”300cm,Savvy balloon5-6mm30-40mm,,,,,,,,,,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,Brite Tip Sheath7F80cm,Smart Carotid stent7-8mm30-40mm,ANGIOG

35、RAPHICCONTROL,Angioguard0.014”300cm,,,,,,,,,,,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,Brite Tip Sheath7F80cm,Smart Carotid stent7-8mm30-40mm,ANGIOGRAPHICCONTROL,Angioguard0.014”30

36、0cm,,,,,,,,,,,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,RETRIEVAL PROTECTION DEVICE,Brite Tip Sheath7F80cm,Smart Carotid stent7-8mm30-40mm,Angioguard0.014”300cm,,,,,,,,,,,,External Ca

37、rotid Artery,Internal Carotid Artery,Common Carotid Artery,Brite Tip Sheath7F80cm,Smart Carotid stent7-8mm30-40mm,RETRIEVAL PROTECTION DEVICE,Angioguard0.014”300cm,Angioguard Device :Capture Sheath Retrieving Fi

38、lter,,,,,,,,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,Brite Tip Sheath7F80cm,Smart Carotid stent7-8mm30-40mm,RETRIEVAL PROTECTION DEVICE,Angioguard0.014”300cm,Angioguard Device :Retr

39、ieved Basket,,,External Carotid Artery,Internal Carotid Artery,Common Carotid Artery,Brite Tip Sheath7F80cm,Smart Carotid stent7-8mm30-40mm,ANGIOGRAPHICCONTROL,,,,External Carotid Artery,Internal Carotid Artery,Comm