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1、Chronic Total Occlusion(CTO) Case Presentation: Key Concepts and Techniques,Takatoshi Hayashi MD Himeji Cardiovascular Center, Japan,2008.4.12 Guangzhou,Role of DES for CTO angioplaty Improve the prognosis?,Recent concepts and techniques Can we treat a patient smartly?,CTO angioplasty,Role of DES fo
2、r CTO angioplaty,CTO angioplasty in DES era,BMS,DES(SES),SICCO,GISSOC,STOP,TOSCA,Nakamura,Hoye,0,60,50,40,10,30,20,(%),Re-occlusion,Restenosis,24%,47%,34%,32%,8%,8%,8%,3%,6%,Nakamura,2%,Ge,3%,9%,9%,SES for CTO lesions: CTO vs Non-CTO Cypher Post Marketing Study (PMS) in Japan,Study Design (Cypher PM
3、S in Japan),Background Post market evaluation to fulfill a Regulatory Approval Condition Purpose To evaluate the safety and efficacy of the Cypher Sirolimus-eluting coronary stent in routine daily practice in the Japanese population Target Enrollment 2,000 patients (1st year=1,000 patients, 2nd year
4、 =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 Criteria Consecutive patients treated with the Cypher stent(including off abel use) Follow-up In-Hos
5、pital,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: 9/1/043/31/05 2nd Year: 4/1/059/30/05,Intent-to-treat,Actual Enrollment,8M Angiographic F/U,12M Clinical F/U,2,054 cases,2,051 cases,1,752 cases
6、,1,857 cases,Follow up Rate： 85.4 90.5,Delivery Success Rate: 99.8%,Study Profile of Cypher PMS in Japan,Lesion Characteristics,(mm),0.31mm,0.22mm,P=0.132,(%),11.2%,8.9%,P=0.453,(%),3.9%,3.9%,P=0.806,Efficacy Evaluation,TLR (12 Months),Late Loss (8 Months),Binary Restenosis (8 Months),MACE to 12 Mon
7、ths Follow-up,Values are n (%). *:Based on ARC Definition *:Excluding 1 case with procedure failure （MI occurred during PCI procedure）,SES for CTO lesions: BMS vs SES Himeji CVC Experience,CTO angioplasty:BMS vs SES,Clinical follow-up: 12Mo Consecutive 181 patients with 185 lesions,BMS group,SES gro
8、up,SES available(2004.8-),(Himeji CVC),CTO angioplasty: BMS vs SES Angiographic results (6Mo-),9.3%,BMS (n=74) (Angio F/U 72%),37.8%,* :P0.001,28.5%,(Himeji CVC),Clinical events during follow-up period,(Himeji CVC),Major adverse cardiac events (MACE),MACE free survival : CTO angioplasty BMS vs SES,(
9、Himeji CVC),Recent concepts and techniques for 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 arguing with a doctor in charge.,Control angiography,AP-Cranial,RAO,T.H 65 y.o M EAP LAD-CTO,C
10、ontrol angiography,Spider view,T.H 65 y.o M EAP LAD-CTO,Strategy: Retrograde or antegrade approach ?,Retry case: Inadequate vessel selection in the first PCI try (Guidewire in high lateral branch) Collateral pathway : very tortuous at distal,How do we treat this case?,T.H 65 y.o M EAP LAD-CTO,Wiring
11、 at LAD,T.H 65 y.o M EAP LAD-CTO,Re-wiring and dilation with a 2.5mm balloon by the physician,T.H 65 y.o M EAP LAD-CTO,Change the Operator,T.H 65 y.o M EAP LAD-CTO,Re-wiring,Parallel wire technique,Guidewire: Conquest, Fielder,T.H 65 y.o M EAP LAD-CTO,Recent advance in CTO angioplasty: Procedural vi
12、ew,Guidewire handling: Parallel guidewire technique Retrograde approach (selected case) IVUS-guided (if possible),Visualization of coronary vessels before PCI MDCT,Anchor balloon technique:Back-up force,Guidewires for CTO lesion,K.S 64 y.o M EAP,RCA,LAD,Cx,LAD,Cx,MDCT(64): Coronary artery,K.S 64 y.o
13、 M EAP,Pre PCI,Pre PCI,Post 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),A guide wire is inserted in a tube and its tip is advanced toward an electronic scale.,The
14、 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 decreases When the guide wire is advanced much further,(0.3g),(0.5g),(0.7g),(0.0g),10mm,Comparison of Tip Stiffness(Guidewire),（
15、）,First Wire,Second Wire,Parallel Guidewire Technique,modified; Tamai, 2007,LAD: Cranial view,LAD: RAO view,First Wire,Second Wire,Second Wire: position A,Second Wire: position B,Second Wire: position B,Second Wire: position A,Distal fibrous cap,First Wire,Second Wire,Sub-intimal space,Sub-intimal s
16、pace,Parallel Guidewire Technique,modified; Tsuchikane et al, 2007,Second wire: stiff, tapered wire,Septal Br.,Diagnal Br.,Septal Br.,Diagnal Br.,Parallel guidewire technique:Advantage,O.T 64 y.o EAP,Control angiography: Cx CTO,O.T 64 y.o EAP,PCI: Cx CTO,O.T 64 y.o EAP,IVUS after first wiring,O.T 64
17、 y.o EAP,IVUS guided wiring,Guidewire: Conquest pro,IVUS cathether,O.T 64 y.o EAP,After re-wiring,RAO view,Guiding cathether:Brite tip 7F JL4 (Cordis- Miami US; Rt. transfemoral) Contralateral angiography:HT-HAYASHI 5F (L-R)(Goodtec; Lt. transradial),Retrograde approach : LAD ostial CTO,Guidewires M
18、iracle primo(2.5g), Conquest （Confianza) Pro (9g；) :Asahi Intecc, Proneur ST(9g):Zeon could not be placed the entry of CTO lesion with IVUS guidance.,Retrograde approach,S.K 67 y.o EAP,Retrograde Wiring,Guiding cathether: XB RCA 6F(Lt. Transradial:Cordis) Guidewire: Runthrough NS floppy (1：Terumo) -
19、 Hydrophilic wire Wire support cathether - RapidTransit (Cordis) 150cm,S.K 67 y.o EAP,POBA and Stenting,After ballooning (1.5mm:Ryujin Plus;Terumo, 1.25mm, 2.5mm :VENT speeder; INVATec), two long (3.0mm*33mm) Sirolimus eluting stents (Cypher; Cordis) were implanted.,Final angiography (Post SES stent
20、ing),S.K 67 y.o EAP,CTO : Strategy of procedure,Antegrade approach,Retrogrde approach,First guidewire,Second guidewire,Pararell wire technique,Success,See-Saw wiring,IVUS-guided wiring,Retry case,Well collateral flow,Conclusions,Now, CTO angioplasty is still challenging, recent development of techno
21、logy and efforts for CTO angioplasty may lead it a front-line therapy.,Drug eluting stent and some procedural techniques may improve the prognosis of patients with CTO lesions.,A lot of RCTs data have shown the good safety and efficacy of Sirolimus-Eluting Stent,Cardiac Death,Non- Cardiac Death,Q-MI
22、,Non- Q-MI,TLR,MACE,2,0,6,8,4,10,%,1.5,0.6,1.5,2.9,0.8,0.7,0.8,0.8,0.6,0.8,2.3,0.7,5.3,4.9,3.1,9.5,8.3,5.8,Japan PMS（Post Marketing Study),SIRIUS,e-Cypher,Clinical follow-up to 1 year (12 months),In daily practice, more than 20% of treatments are complex lesions like in stent restenosis, etc.,TLR Pr
23、edictors： 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 year.,A Fight with CAD,Study Design (Cypher PMS in Japan),Background Post market evaluati
24、on to fulfill a Regulatory Approval Condition Purpose To evaluate the safety and efficacy of the Cypher Sirolimus-eluting 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 (Sele
25、ct sites on basis of balanced population density, hospitals distribution as well as scale of hospitals) Method Prospective Non-randomized Registry Inclusion Criteria Consecutive patients treated with the Cypher stent (including off label use) Follow-up In-Hospital,3,8 months and 1,2,3,4,5 years clin
26、ical follow-up data Angiographic follow-up is mandated at 8 months（Analysis:Core lab),PMS site,Hokuto Cardiovascular Hospital Sunagawa City Hospital Iwate Prefectural Central Hospital South Miyagi Medical Center Katta Hospital Hoshi General Hospital Ohra Nishinouchi Hospital Niigata City General Hos
27、pital Tsukuba Medical Center Hospital Saiseikai Kurihashi Hospital Kimitsu Central Hospital Showa University Hospital Teikyo University Hospital Mitsui Memorial Hospital International Medical Center of Japan Toranomon Hospital Itabashi chuo Medical Center Toho University Ohashi Medical Center Sakaki
28、bara Heart Institute Metropolitan Bokutou Hospital Shonan Kamakura General Hospital Tokai University Hospital Yokohama Sakae Kyosai Hospital Kanagawa Cardiovascular and Respiratory Center Comfort Hospital Toyohashi Heart Center Shizuoka City Shizuoka Hospital Aichi Medical University Anjo Kosei Hosp
29、ital Nagoya Diini Red Cross Hospital Shiga Medical Center for Adults Kyoto-Katura Hospital Kyoto Second Red Cross Hospital Kyoto Universtiy Hospital Otowa Hospital National Cardiocascular Center Rinku General Medical Center Osaka Red Cross Hospital Osaka City University Hospital Kansai Rosai Hospita
30、l Himeji Cardiovascular Center Tokushima Red Cross Hospital Kurashiki Central Hospital Tuchiya General Hospital Matsue City Hospital Tokuyama Central Hospital Fukuoka City Medical Association Hospital Kokura Memorial Hospital National Hospital Organization Oita Medical Center Okinawa Chubu Hospital
31、Miyazaki Medical Association Hospital,Number of hospitals,Enrollment Period 1st Year: 9/1/043/31/05 2nd Year: 4/1/059/30/05,Intent-to-treat,Actual Enrollment,8M Angiographic F/U,12M Clinical F/U,2,054 cases,2,051 cases,1,752 cases,1,857 cases,Follow up Rate： 85.4 90.5,Delivery Success Rate: 99.8%,Study Profile of Cypher PMS in Japan,