慢性完全性闭塞病变的病情介绍重要概念和技术英文

1、慢性完全性闭塞病变的病情介绍重要概念和技术英文Role of DES for CTO angioplaty Improve the prognosis?Recent concepts and techniques Can we treat a patient smartly?CTO angioplastyRole of DES for CTO angioplatyCTO angioplasty in DES eraBMSDES(SES)SICCOGISSOCSTOPTOSCANakamura Hoye 0605040103020(%)Re-occlusionRestenosis24%47%34

2、%32%20%12%8%8%8%3%6%Nakamura2%Ge 3%9%9%SES for CTO lesions:CTO vs Non-CTOCypher Post Marketing Study(PMS) in JapanStudy Design (Cypher PMS in Japan) BackgroundPost market evaluation to fulfill a Regulatory Approval Condition PurposeTo evaluate the safety and efficacy of the Cypher Sirolimus-eluting

3、coronary stent in routine daily practice in the Japanese population Target Enrollment 2,000 patients (1st year=1,000 patients, 2nd year =1,000patients) No of Sites 50 sites (Select sites on basis of balanced population density, hospitals distribution as well as scale of hospitals) Method Prospective

4、 Non-randomized Registry Inclusion CriteriaConsecutive patients treated with the Cypher stent(including off abel use) Follow-up In-Hospital,3,8 months and 1,2,3,4,5 years clinical follow-up data：Angiographic follow-up is mandated at 8 months（Analysis:Core lab)Enrollment Period 1st Year: 9/1/043/31/0

5、5 2nd Year: 4/1/059/30/05Intent-to-treatActual Enrollment8M Angiographic F/U12M Clinical F/U2,054 cases2,051 cases1,752 cases1,857 casesFollow up Rate： 85.490.5Delivery Success Rate: 99.8%Study Profile of Cypher PMS in JapanCTONon-CTOP ValueNo of lesions109(105pts)2,350(1946pts)RVD, mm 2.280.702.570

6、.600.001Lesion Length, mm26.917.117.29.90.001ACC/AHA TypeB2/C*109 (100.0)1,872 (80.0)12MoConsecutive 181 patients with 185 lesionsBMSgroupSESgroupSES available(2004.8-)(Himeji CVC)CTO angioplasty: BMS vs SESAngiographic results (6Mo-)9.3%BMS(n=74)(Angio F/U 72%)Re-occlusionRestenosis37.8%* :P0.0014.

7、5%4.5%SES(n=66)(Angio F/U 85%)9.0%*4.5%28.5%(Himeji CVC)Clinical events during follow-up period AMI 1(non-fetal)0Cardiac Death 00TLR 22 cases6 cases PCI 16 cases6 cases CABG 6 cases0 casesBMS(n=103)SES(n=78)(Himeji CVC)Major adverse cardiac events (MACE)MACE free survival : CTO angioplastyBMS vs SES

8、(Himeji CVC) p0.005Breslow-Gehan-WilcoxonBMS(n=103)SES(n=78)daysRecent concepts and techniquesfor CTO angioplasty 65 y.o M EAP DM, HT Retry Case (unsuccessful； 3 month before) Case A PCI Case of LAD-CTO, treated in a certain country in East-South Asia with arguingwith a doctor in charge.Control angi

9、ography AP-CranialRAOT.H 65 y.o M EAP LAD-CTOControl angiography Spider viewT.H 65 y.o M EAP LAD-CTOStrategy:Retrograde or antegrade approach ?Retry case:Inadequate vessel selection in the first PCI try (Guidewire in high lateral branch)Collateral pathway : very tortuous at distalHow do we treat thi

10、s case?Antegrade approachT.H 65 y.o M EAP LAD-CTOWiring at LADT.H 65 y.o M EAP LAD-CTORe-wiring and dilation with a 2.5mmballoon by the physicianT.H 65 y.o M EAP LAD-CTOChange theOperatorT.H 65 y.o M EAP LAD-CTORe-wiringParallel wire techniqueGuidewire: Conquest, FielderT.H 65 y.o M EAP LAD-CTORecen

11、t advance in CTO angioplasty: Procedural view Guidewire handling: Parallel guidewire technique Retrograde approach (selected case) IVUS-guided (if possible)Visualization of coronary vessels before PCI MDCTAnchor balloon technique:Back-up forceGuidewires for CTO lesionK.S 64 y.o M EAPRCALADCxLADCxMDC

12、T(64):CoronaryarteryK.S 64 y.o M EAPPre PCIPre PCIPost PCI (SES implanted)K.S 64 y.o M EAP The stiffness of a guide wire : expressed as the resistance of the tip to bending (1cm from tip) against force (g)(measured by Asahi Intecc.Co)Guide wireA guide wire is insertedin a tube and its tip is advance

13、d toward an electronic scale.The reading on the electronic scale increases when the guide wire is pressed against the sale.The reading increases more when the guide wire is advanced further. The reading decreasesWhen the guide wireis advanced much further(0.3g)(0.5g)(0.7g)(0.0g)10mmComparison of Tip

14、 Stiffness(Guidewire) （）First WireSecond WireParallel Guidewire Techniquemodified; Tamai, 2007LAD: Cranial viewLAD: RAO viewFirst WireSecond WireSecond Wire: position ASecond Wire: position BSecond Wire: position BSecond Wire: position ADistal fibrous capFirst WireSecond WireSub-intimal spaceSub-int

15、imal spaceParallel Guidewire Techniquemodified; Tsuchikane et al, 2007Second wire: stiff, tapered wireSeptal Br.Diagnal Br.Septal Br.Diagnal Br.Parallel guidewire technique:AdvantageAvoid 2nd guidewire advance into the sub-intimal space made by 1st guidewireAvoid more dilation of sub-intimal spacema

16、de by 1st guidewireLandmark for guidewire handlingLess use of contrast agentChange the geometry of lesions or vesselO.T 64 y.o EAPControl angiography: Cx CTOO.T 64 y.o EAPPCI: Cx CTOO.T 64 y.o EAPIVUS after first wiringO.T 64 y.o EAPIVUS guided wiringGuidewire: Conquest proIVUS cathetherO.T 64 y.o E

17、APAfter re-wiringRAO viewGuiding cathether:Brite tip 7F JL4 (Cordis- Miami US; Rt. transfemoral)Contralateral angiography:HT-HAYASHI 5F (L-R)(Goodtec; Lt. transradial)Retrograde approach : LAD ostial CTOLADLCxLMTGuidewiresMiracle primo(2.5g), Conquest （Confianza) Pro (9g；) :Asahi Intecc, Proneur ST(

18、9g):Zeon could not be placed the entry of CTO lesion with IVUS guidance. Retrograde approachS.K 67 y.o EAPIVUSGuidewire:GW at high lateral branchLAD ostialLCxDistal tip of the wire support catheterSeptal vesselsGuidewire (GW) at LAD Runthrough NS (floppy)Retrograde WiringGuiding cathether: XB RCA 6F

19、(Lt. Transradial:Cordis)Guidewire: Runthrough NS floppy (1：Terumo) - Hydrophilic wireWire support cathether - RapidTransit (Cordis) 150cmS.K 67 y.o EAPPOBA and StentingAfter ballooning (1.5mm:Ryujin Plus;Terumo, 1.25mm, 2.5mm :VENT speeder; INVATec), two long (3.0mm*33mm) Sirolimus eluting stents (C

20、ypher; Cordis) were implanted.Final angiography(Post SES stenting)S.K 67 y.o EAPCTO : Strategy of procedureAntegrade approachRetrogrde approachFirst guidewireSecond guidewirePararell wire techniqueSuccessSee-Saw wiringIVUS-guided wiringRetry caseWell collateral flowConclusions Now, CTO angioplasty i

21、s still challenging, recent development of technology and efforts for CTO angioplasty may lead it a front-line therapy. Drug eluting stent and some proceduraltechniques may improve the prognosis of patients with CTO lesions. A lot of RCTs data have shown the good safety and efficacy of Sirolimus-Elu

22、ting StentCardiacDeathNon-CardiacDeathQ-MINon-Q-MITLRMACE2068410%1.50.61.52.90.80.70.80.80.60.82.30.75.34.93.19.58.35.8Japan PMS（Post Marketing Study)SIRIUSe-CypherClinical follow-up to 1 year (12 months)In daily practice, more than 20% of treatments are complex lesions like in stent restenosis, etc

23、.TLR%PValueOddsRatioNYDialysis3.715.20.0010.215RVD 3.5mm2.25.20.0010.414Mod/Sev Calcification3.36.930mm3.36.90.0010.463Diabetes3.35.70.0120.563In Stent Restenosis3.45.60.0280.596Multi- vessel disease3.55.40.0430.631Prior to PCI3.35.10.0520.625Bifurcation3.45.00.0600.661ACC/AHA Type B2C2.44.30.0710.5

24、45Multi- lesion Treatment 4.25.80.3170.707LAD4.33.50.3811.213Prior to MI4.54.10.7021.095TLRPredictors：Japan PMS(1 year)Purpose We evaluated the clinical results of complex lesions after Cypher Sirolimus-eluting stent implantation as sub-analysis of Cypher Post Marketing Study (PMS) Interim data to 1

25、 year.A Fight with CADStudy Design (Cypher PMS in Japan) BackgroundPost market evaluation to fulfill a Regulatory Approval Condition PurposeTo evaluate the safety and efficacy of the Cypher Sirolimus-eluting coronary stent in routine daily practice in the Japanese population Target Enrollment 2,000

26、patients (1st year=1,000 patients, 2nd year =1,000patients) No of Sites 50 sites (Select sites on basis of balanced population density, hospitals distribution as well as scale of hospitals) Method Prospective Non-randomized Registry Inclusion CriteriaConsecutive patients treated with the Cypher sten

27、t (including off label use) Follow-up In-Hospital,3,8 months and 1,2,3,4,5 years clinical follow-up dataAngiographic follow-up is mandated at 8 months（Analysis:Core lab)PMS siteHokuto Cardiovascular HospitalSunagawa City HospitalIwate Prefectural Central Hospital South Miyagi Medical CenterKatta Hos

28、pital Hoshi General HospitalOhra Nishinouchi HospitalNiigata City General HospitalTsukuba Medical Center HospitalSaiseikai Kurihashi HospitalKimitsu Central HospitalShowa University HospitalTeikyo University HospitalMitsui Memorial HospitalInternational Medical Center of JapanToranomon HospitalItaba

29、shi chuo Medical CenterToho University Ohashi Medical CenterSakakibara Heart InstituteMetropolitan Bokutou HospitalShonan Kamakura General HospitalTokai University Hospital Yokohama Sakae Kyosai HospitalKanagawa Cardiovascular and Respiratory CenterComfort Hospital Toyohashi Heart Center Shizuoka City