醫(yī)學(xué)交流課件：顱內(nèi)動(dòng)脈支架的前世今生與明天

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1、顱內(nèi)動(dòng)脈支架與顱內(nèi)動(dòng)脈狹窄（ICAS）和顱內(nèi)動(dòng)脈瘤（IAn）冠脈球擴(kuò)支架Off Lable使用Higashida RT，于1998 報(bào)道了國際首例IAn支架輔助栓塞術(shù)1例復(fù)發(fā)性出血的VBA梭型動(dòng)脈瘤Feldman RL，于1997 報(bào)道了國際首例ICAS支架成形術(shù)1例抗栓治療失敗的顱內(nèi)頸動(dòng)脈狹窄顱內(nèi)動(dòng)脈支架的研發(fā)和應(yīng)用起步晚，較冠脈支架晚10年n For patients who failed to medical therapyn born in 1997 in the world by RL Feldmann We successfully completed the first case

2、 in China in 2001 n Back then, reported cases in English literature 50 ICAS支架的前世Major block for the use of ICAS stentingn ICHn SAHn IVHn Perforator str.n Thrombosisn Embolic str.n Dissection n So onStroke complication10-40%ICHSAHEmbolic str.PSICAS支架的前世ICAS支架的前世解剖因素支架因素行程迂曲柔順性差管壁薄弱命名壓高穿支動(dòng)脈命名壓高ICAS支架的

3、前世ICAS支架的前世摸索出在S-660、Express、Cypher和BiodivYsio冠脈支架中， BiodivYsio似乎最好用Apollo支架系統(tǒng) 2002年獲專利 2004年獲SFDA批準(zhǔn) 國內(nèi)第一個(gè)ICAS專用支架 比美國同類產(chǎn)品Wingspan 支架系統(tǒng)早2年上市 ICAS支架的今生ICAS支架的今生AJNR Am J AJNR Am J NeuroradiolNeuroradiol 2007,28(5):830-42007,28(5):830-4國內(nèi)首例阿波羅支架植入ICAS支架的今生On August 3, 2005, the Wingspan System was app

4、roved under a Humanitarian Use Device (HDE).The original indication was for treatment of refractory intracranial atherosclerotic disease with a stenosis of at least 50%ICAS支架的今生ICAS支架的今生國內(nèi)首例Wingspan支架植入ICAS支架的今生SAMMPRIS TrialDerdeyn and Chimowitz et al. reported the final results of SAMMPRIS trial o

5、n October 26, 2013 in LancetOccurring Time of Primary Endpoint EventsMedical Group N=227Stenting Group N=224P ValueDuring a median 324 months15% (34/227)23% (52/224)0.01Within 30 days5.8% (13/227)14.7% (33/224)0.01Beyond 30 days*9.3% (21/227)8.5% (19/224)NS*Assuming none of the patients who withdrew

6、 or lost to follow-up between the two groups had a primary endpoint event, though more patients withdrew or were lost in the medical group than in the stening group (24 10.6% versus 10 4.5%, P=0.0193)ICAS支架的今生VISSIT TrialZaidat et al. reported the final results of VISSIT trial on March 24, 2015 in J

7、AMA Occurring Time of Primary Endpoint EventsMedical Group N=53Stenting Group N=58P ValueStroke in the same territory within 1 y of randomization9.4% (5/53)34.5% (20/58)0.01Within 30 days5.7% (3/53)24.1% (14/58)0.01ICAS支架的今生ISN=2/3 IS-PREN=1/1 Microwire success N=213 SAMMPRIS PTAS Arm N=224 Decline

8、N=4 Compliance with angiography N=220 Abort N=6 OcclusionN=3ResolutionN=1Dissection N=1Adjacent an. N=1Microwire passing attempt N=214 Direct stent placement N=2 Failure N=1 Balloon angioplasty N=211 Stent placement N=206 HemorrhageN=13Symptomatic N=11IS or CITS N=21Asymp. SAH N=1SAHN=63WP, 1VRCITS

9、N=2ICHN=7IS N=19Embolic N=3Perforator N=14*Perforator N=1Embolic N=1Perforator Total N=15Late thromb. N=2/6*Perforating stroke alone, N=12; Mix with embolism, N=2PI was the most common complication after ICAS stentingI have stented more than 1000 ICAS patients over 3 periods since 2001, created a se

10、ries of safety core techs of ICAS stenting with a marvelous return ComplicationThe Initial The Second The Recent BES（N=169）01.9-04.11BES/SES（N=317）04.12-09.12SES（N=100）07.1-09.2BES/SES（216）10.1-13.9Overall-n（%）19(11.2)21(6.6)7(7)8(5.1)Severe-n（%）10(5.9)15(4.7)5(5)5(3.2)Sym ICH4(2.4)6(1.9)2(2)3(1.4)

11、Fatal2(1.2)0(0)0(0)0(0) non-fatal2(1.2)6(1.9)2(2)3(1.4)Ischemic str.6(3.6)9(2.8)3(2)4(1.9) PS5(3.0)4(1.3)1(1)2(0.9） EBS1(0.6)4(1.3)2(2)1(0.5)Thrombosis0(0)1(0.3)0(0)1(0.5)Death-n（%）2(1.2)1(0.3)0(0)0(0)10(5.9)2(1.2)7（3.2）0（0）15(4.7）1(0.3）ICAS支架的今生p與術(shù)者經(jīng)驗(yàn)有關(guān)p 與支架類型有關(guān)ICAS支架的今生安全性ICAS支架的今生ICAS支架的今生ICAS支架的

12、今生pThe FDA analyzed available clinical evidence and concluded that evidence from the original HDE study suggests probable benefit with use of the Wingspan Stent System for a specific population of patientspThe FDA determined that Wingspan should remain available for those patients who have failed to

13、 respond to, or who are ineligible for, an aggressive and comprehensive program of medical managementICAS支架的今生p Wingspan is now approved only for patients who are between 22 and 80 years old AND who meet ALL of the following criteria: who have had 2 or more strokes despite aggressive medical managem

14、ent; whose most recent stroke occurred more than seven days prior to planned treatment with Wingspan; who have 70-99% stenosis due to atherosclerosis of the intracranial artery related to the recurrent strokes; and who have made good recovery from previous stroke and have a modified Rankin score of

15、3 or less prior to Wingspan treatment.The safety advisory notes specifically ICAS支架的今生p the treatment of stroke with an onset of symptoms within 7 days or less of treatment; orp the treatment of . TIAs.The Wingspan Stent System should not be used for:ICAS支架的今生p For healthcare providers: Physicians s

16、hould be aware that the Wingspan Stent System is approved by the FDA as a Humanitarian Use Device, the statement notes. Generally, a patient may be treated with Wingspan only if its use has been approved in advance by the treating physicians Institutional Review Board (IRB) The physician is responsi

17、ble for obtaining IRB approval before Wingspan is administered to or implanted in a patient. Specific recommendationsICAS支架的今生p For neurologists: Select patients carefully after reviewing the new device labeling. Become familiar with the design and results of the SAMMPRIS trial. If your patient expe

18、riences a complication following treatment with the Wingspan System, please file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Specific recommendationsICAS支架的今生p For neurointerventionalists: Thoroughly review the revised training program for Wingspan. A s

19、ummary of these changes is included in the new labeling Instructions for Use. Report any device problems to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Specific recommendationsICAS支架的今生ICAS支架的今生一、球囊擴(kuò)張支架似乎不適合于治療ICAS它不是經(jīng)微導(dǎo)管遞送，潛在大損傷二、開環(huán)自膨支架不是最適合于治療ICAS開環(huán)的環(huán)端

20、可能進(jìn)入穿支，使其閉塞現(xiàn)在獲準(zhǔn)使用的ICAS支架在安全性方面都有缺陷ICAS支架的明天閉環(huán)自膨支架如何？To report the outcomes of patients with symptomatic MCA stenosis after individual implantation of open or close cell self-expanding stentsObjectiveInclusion criteria p An angiographically verified 70%-95% MCA stenosis, situated at origin, trunk or

21、bifurcationp Ischemic stroke with NIHSS score 10mm Long Lesion, %8.6 (3/35)38.0 (19/50)Any Stroke & Death within 30d, %2.9 (1/35)4.0 (2/50)Any Stroke & Death within 30d plus Ipsilateral ischemic stroke , %8.6 (3/35)10.0 (5/50 )ISR, %23.5 (4/17)22.7 (5/22)Conclusionp Our findings suggest that we should develop close cell self-expanding stent for ICAS安全性年代冠脈球擴(kuò)支架前世1997阿波羅球擴(kuò)支架今生開環(huán)自膨支架2003200120052006閉環(huán)自膨支架2012經(jīng)擴(kuò)張球囊導(dǎo)管遞送的閉環(huán)自膨支架明天2017？國外使用國內(nèi)使用ICAS支架的前世今生和明天