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1、CEA and Stroke Prevention in China,Douglas J.Wirthlin,M.D.Division of Vascular SurgeryDepartment of Cardiovascular MedicineIntermountain Health Care,Salt Lake City,Utah,1996-2000,8258 strokes,10 populations 75%CT scans,Stroke 2003;34:2091-6,Causes of Stroke in China,20%,Carotid Endarterectomy(CEA)in
2、 USA 2%mortality 0-5%stroke rate 1-2 day LOS 10 x reduction in stroke risk,North American Symptomatic Carotid Endarterectomy Trial(NASCET),NEJM 325:445;1991,Asymptomatic Carotid Atherosclerosis Study(ACAS),*JAMA 273:1421,1995,CEA only effective if:1.outcomes are good 2.expected patient survival 2-5
3、years,Carotid Endarterectomy in Mainland China,Douglas J Wirthlin MD,Qin Yi Zhang MD,Gen Xue Qu MD,Jian Lin Liu MD,Xeng Meng MD,Raphael C Sun BS,Nai Dong Wang MD,Donald B Doty MD.Xian Jian Tong University No.1 Xian,Peoples Republic of ChinaIntermountain Health Care,LDS Hospital,Salt Lake City,Utah,F
4、ebruary 2002 presentFebruary 2002 July 20042 exchanges in USA2 exchanges in China,Results,(4/02-7/04)104 CEA performed in 4 hospitalsUS surgeon(3 cases),Demographics,65 CEA in 60 patients48 male,12 femaleHypertension 47(78%)Hypercholesterolemia 57(95%)Smoking 31(52%)Diabetes 14(23%),Neurologic Prese
5、ntation,Asymptomatic 0(0%)TIA 4(7%)Stroke 61(93%)Minor36(67%)Major22(33%),62 y/o man Smoking,HTN R MOB L Sided weakness Bilateral ICA occlusions,Operative Technique,General Anesthesia64(98%)Shunt64(98%)Longitudinal Endart.65(100%)Primary closure59(91%)Prosthetic patch 6(9%),30 day Outcomes,Mortality
6、0(0%)MI0(0%)Neurologic events 4(6%)Major3(5%)Minor(TIA)1(2%)CN injury6(10%)Bleeding 1(2%),LOS/Hospital Charges,Mean LOS 26+20 days(10-127d)Mean Operative Charges 13,389+4937 RMB(1,613+595 US$)Mean Total Charges 24,151+2557 RMB(2,909+308 US$),With adequate training,Carotid Endarterectomy(CEA)in China
7、 is very safe and effective,CEA in USA:200,000 cases/yearCEA in China:200 cases/year,Why so few CEA in China?No formal training Poor outcomes(in the past)Patients present with advanced disease CEA developed concurrent with CAS Financial incentives for CAS over CEA Limited Referrals from medical doct
8、ors Patient fear of surgery,History of CEA in USA,First CEA 19541960s 1980s improvement in surgical technique and understanding of cerebrovascular disease.,History of CEA in USA,1970s-80s Efficacy of CEA questioned1990s Randomized trials establish CEA as the treatment of choice for high-grade caroti
9、d stenosis over“best medical therapy.”(NASCET&ACAS),North American Symptomatic Carotid Endarterectomy Trial(NASCET),50 centers US&Canada(qualified based on 70%),NEJM 325:445;1991,NASCET(stenosis 70%),Asymptomatic Carotid Atherosclerosis Study(ACAS),NIH sponseredAsymptomatic patients(low surgical ris
10、k)w/60%stenosis Angiography not mandatoryAngiographic related stroke 1.2%,*JAMA 273:1421,1995,ACAS,*JAMA 273:1421,1995,History of CEA in USA,CEA becomes the“gold standard”for treatment of extra-cranial carotid stenosis.Guidelines for CEA are established.Rate of CEA increases.(200,000 CEA/yr),Indicat
11、ions for CEA,Asymptomatic 70%stenosis 50%stenosis w/large ulcerTIA 70%stenosis 50%stenosis w/large ulcerPrevious StrokeStable/Improving neurologic exam 70%stenosis 50%stenosis w/large ulcerEvolving Stroke 70%stenosisGlobal Symptoms 70%stenosis and uncorrectable vertebrobasilar disease,AHA Standards
12、for CEA(1989),CEA only effective if:1.outcomes are good 2.expected patient survival 2-5 years,History of CEA in USA,1990s Carotid Angioplasty and Stent(CAS)introduced.2000 Cerebral protection devices introduced and outcomes of CAS appear comparable to CEA.Randomized prospective trial establishes CAS
13、 equivalent to CEA in high-risk symptomatic patients(SAPPHIRE).Currently the role of CEA is being redefined.,History of CEA in China,Stroke awareness,prevention,and treatment recently became a priority for ChinaNo formal training for CEA.Few reports of CEA in China22 CEA,Zhongshan Hospital,Fudan Uni
14、versity,Shanghai(Chin Med J 2002;115(3):405-862 CEA,Queen Mary Hospital,University of Hong Kong Medical Center,Hong Kong(Chin Med J 2002;115(4):536-9105 CEA,Sino-American Stroke GroupCAS is rapidly becoming an accepted treatment option for carotid stenosis.,Carotid Revascularization:which is better?
15、,Clinical Effectiveness,Case Series(w/cerebral protection)All patients Perioperative outcomes of CEA and CAS comparable 0-5%stroke and death rate Cranial Nerve DeficitCEA 0 10%CAS 0%RestenosisCEA 0 20%,4%clinically significantCAS 5 10%12-24 months,most retreated with PTA/stent,Protected Carotid-Arte
16、ry Stenting versus Endarterectomy in High-Risk Patients(SAPPHIRE),Randomized,prospective trial in highly qualified centers for both CEA and CAS334 High-risk patients(asymptomatic and symptomatic)randomized.Designed to determine if CAS is inferior to CEAEndpoints:stroke,MI,death,and cranial nerve inj
17、ury(30 day and 12 month),NEJM 2004 351(15):1493-1501,SAPPHIRE High-risk Criteria,Age 80CardiacCABG 50%FEV1 3.0AnatomicPrevious CEASevere tandem lesionCervical RadiationContralateral carotid occlusionHigh cervical lesion C2Lesion below clavicleContralateral laryngeal palsy,SAPPHIRE,Endarterectomy ver
18、sus Stenting in Patients with Severe Carotid Stenosis,Multicenter,randomized european trial,symptomatic patients(stenosis 60%)Stroke or death at 30 days and 6 months30 day stroke/death CEA 3.9%,CAS 9.6%2.5 relative risk increase for stroke/death CAS vs.CEA6 month stroke/death CEA 6.1%,CAS 11.2%(p=0.
19、02)Stopped after 527 patientd secondary to significant advantage of CEA,NEJM 355:1660-1;2006,Current Guidelines CEA or CAS?,Good Surgical RiskAsymptomatic patients?Symptomatic patients?CREST trialHigh Surgical Risk AsymptomaticCAS vs.?medical mgt.Symptomatic CAS?,History of Carotid Disease Treatment
20、:USA and China,First CEA1954,Efficacy of CEA validated:ACAS,NASCET 1990s,CAS developed 1990s,CAS protection devices 2000,SAPHIRE 2004,CAS regulated by Government 2005,CAS outcomes inferior to CEA in Europe NEJM 2006,CEA Reports:22 cases Shanghai 2002,62 cases Hong Kong 2002,SinoAmerican Stroke Group
21、 105 CEA,2004,First CEA/CAS?1990-2000,Resource Utilization&Cost,EquipmentOperating RoomSurgical InstrumentsPersonnelTrained SurgeonAnesthesiologistCostOperative 13,389+4,937 RMBTotal 24,151+2,557 RMB,EquipmentAngiography suiteWires,catheters,balloons,stents,protection devicePersonnelTrained Interven
22、tionalistCost 70,000 RMB,CEA,CAS,Cost of Treating Carotid Artery Disease,Stroke CAS CEA,Patient Education/Physician Education,Risk Factor Modification,Screening Programs,Medicine,CAS,CEA,CVD Stroke Prevention Plan,Patient Education/Physician Education,Risk Factor Modification,Screening Programs,Medicine,CAS,CEA,CVD Stroke Prevention Plan,Recommendations,Promote Patient and Physician EducationInitiate Carotid Screening programsEstablish training center and standards for CEAMonitor outcomes,
