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经桡动脉治疗 LM 分叉病变. 中国医学科学院 阜外心血管病医院 杨跃进 MD, PhD, FACC. TCC 2009,09/06/23-26 北京. 内容提要. 经股动脉介入( TFI )的问题 TRI 的优势 TRI 的发展现状 TRI 治疗 LM 分叉病变 TRI 治疗 LM 分叉病变的风险. TFI 的问题明显. 强迫卧床 24 小时:患者难忍 诱发 DVT+ 肺栓塞致死风险! 穿刺血管并发症:局部出血,血肿, 腹膜后血肿致死风险! 血管封堵:费用增加 短期( <3ms )内不能再用
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经桡动脉治疗LM分叉病变 中国医学科学院 阜外心血管病医院 杨跃进 MD, PhD, FACC TCC 2009,09/06/23-26 北京
内容提要 • 经股动脉介入(TFI)的问题 • TRI 的优势 • TRI 的发展现状 • TRI 治疗LM分叉病变 • TRI治疗LM分叉病变的风险
TFI的问题明显 • 强迫卧床24小时:患者难忍 诱发DVT+肺栓塞致死风险! • 穿刺血管并发症:局部出血,血肿, 腹膜后血肿致死风险! • 血管封堵:费用增加 短期(<3ms)内不能再用 有失败率
TRI的优势突出 • 穿刺桡动脉:更微创 无局部大出血致死风险! • 术后下床活动:患者无痛苦,易接受 无诱发DVT+肺栓塞致死风险! • 宿短住院日:节省住院费用 • 建立TRI微创新模式
我国TRI的发展现状 • 已有>10年经验 • 技术已成熟:与TFI一样 • 队伍已壮大 • 已形成大趋势 • 国际先进甚致领先
Numbers of PCI @ Fu Wai Each Year 80.22% in 2007
TRI now widespreadly Used in China as well as in the word • >50% sites in China • >80% cases in Fuwai hospital as well as other university hospitals • A lot of centers in Europe, Japan and Asia
我国TRI 10余年经验 • 开拓者的带头作用:影响一单位 • 开拓单位的示范作用:带动一地区 • 全国开拓单位的合力:带动了全国 • 技术精英的执着:攻克了技术难关 推动了TRI的发展 • 会议,直播,培训班:规范提高了TRI技术
我国TRI 技术已趋成熟 • 简单病变 • 复杂病变:双支架 技术 • 高危病变:LM病变 • 高难病变:CTO病变 • 高危病人和病变
New Technology Currently Used for Complicated Lesions • For CTO: final stronghold antigrade approach retrograde approach • For LM: high risk one-stent techniques two-stent for bifurcations • For bifurcation: complicated one stent technique two stent technique DK crush Cullotte SKS provisional T TAP
New Technology for Complicated Lesions in TRI • For CTO: anti-grade approach retro-grade approach • For LM: one-stent technique two-stent techniques for LM bifurcation • For bifurcation: one-stent technique two-stent techniques step DK crush step DK inverse crush step cullotte step kissing stent provisional T TAP
LM bifurcation PCI: Strategy • One stent strategy: Crossover +balloon kissing • Two stents strategy: Crush(classic, step,reverse, Inverse, provisional) Modify T Kissing(V)and step kissing Stent Cullote Stent
DES for LM: Principles • Indication: Class Ⅲ First choice :CABG instead of PCI Unless: CABG contra. & PCI eligiable • LM ostium&body: PCI can replace CABG because of low mortality • LM CTO & in-stent restenosis:CABG • Lower LVF or high risk of acute closure: IABP needed Baim DS, Mauri L, Cutlip DC. Drug-eluting stenting for unprotected left main coronary artery disease: are we ready to replace bypass surgery? JACC 2006;47:878-81.
SYNTAX Trial Design 62 EU Sites 23 US Sites All Pts with de novo 3VD and/or LM disease (N=4,337) • Treatment preference (9.4%) • Referring MD or pts. refused informed consent (7.0%) • Inclusion/exclusion (4.7%) • Withdrew before consent (4.3%) • Other (1.8%) • Medical treatment (1.2%) 71% enrolled (N=3,075) + Heart Team (surgeon & interventionalist) Total enrollment N=3075 Amenable for both treatment options Amenable for only one treatment approach Stratification: LM and Diabetes DM 28.2% NonDM 71.8% Stratification: LM and Diabetes DM 28.5% Non DM 71.5% Randomized Arms N=1800 Two Registry Arms N=1275 Randomized Arms n=1800 Two Registry Arms PCI N=198 PCI all captured w/ follow up CABG N=1077 CABG n=1077 CABG 2500 750 w/ f/u CABG n=897 TAXUS n=903 PCI n=198 TAXUS* N=903 vs CABG N=897 no f/u n=428 5yr f/u n=649 vs LM 33.7% 3VD 66.3% LM 34.6% 3VD 65.4%
SYNTAX score Patient Profiling Local Heart team (surgeon & interventional cardiologist) assessed each patient in regards to: • Patient’s operative risk (EuroSCORE & Parsonnet score) • Coronary lesion complexity (newly developed SYNTAX score) • The goal of the SYNTAX score is to provide a tool to assist physicians in their revascularization strategies for patients with high risk lesions Number & location of lesions Dominance Left Main Calcification 3 Vessel Thrombus Total Occlusion Bifurcation Tortuosity • Leaman score, Circ 1981;63:285-299 • Lesions classification ACC/AHA , Circ 2001;103:3019-3041 • Bifurcation classification, CCI 2000;49:274-283 • CTO classification, J Am Coll Cardiol 1997;30:649-656 Sianos et al, EuroIntervention 2005;1:219-227 Valgimigli et al, Am J Cardiol 2007;99:1072-1081 Serruys et al, EuroIntervention 2007;3:450-459 Coronary tree segments based on the classification proposed by the AHA and modified for the ARTS study Circulation 1975; 51:31-3 & Semin Interv Cardiol 1999; 4:209-19
Adverse Events to 12 Months CVA (Stroke) All Death Myocardial Infarction Revascularization TAXUS* (N=903) CABG (N=897) ITT population Event Rate ± 1.5 SE, *Fisher exact test
Revascularization* to 12 MonthsLeft Main Subset CABG(N=348) TAXUS(N=357) 40 20 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P=0.02* 12.0% 6.7% *Any revascularization (PCI or CABG); ITT population Event rate ± 1.5 SE, *Fisher exact test
MACCE to 12 MonthsLeft Main Subset CABG(N=348) TAXUS(N=357) 40 20 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P=0.44* 15.8% 13.6% Event rate ± 1.5 SE, *Fisher exact test ITT population
MACCE to 12 Months by SYNTAX Score TertileLow Scores (0-22) LM Subset CABG(N=103) TAXUS(N=118) 40 Mean baseline SYNTAX Score CABG 15.5 ± 4.3 TAXUS 15.7 ± 4.4 20 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P=0.19* 13.0% 7.7% Event rate ± 1.5 SE, *Fisher exact test Calculated by core laboratory; ITT population
CABG(N=92) TAXUS(N=195) 40 Mean baseline SYNTAX Score CABG 27.2 ± 3.0 TAXUS 27.0 ± 2.7 20 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation MACCE to 12 Months by SYNTAX Score TertileIntermediate Scores (23-32) LM Subset P=0.54* 15.5% 12.6% Event rate ± 1.5 SE, *Fisher exact test Calculated by core laboratory; ITT population
CABG(N=150) TAXUS(N=135) 40 Mean baseline SYNTAX Score CABG 42.1 ± 7.6 TAXUS 43.8 ± 9.1 20 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation MACCE to 12 Months by SYNTAX Score TertileHigh Scores (33) Left Main Subset P=0.008* 25.3% 12.9% Event rate ± 1.5 SE, *Fisher exact test Calculated by core laboratory; ITT population
Overall MACCE at 12 MonthsLeft Main Subset CABG TAXUS P=0.44 P=1.0 P=0.27 P=0.29 P=0.42 Patients (%) (n=705) (n=91) (n=138) (n=218) (n=258) ITT population
LM-PCI: Evaluation and Stratification • Procedural risk----safety !!! • Strategy ---- feasibility • Prognosis---- acute & subacute ST • Long term outcomes ---- MACE • Single LM & low risk---- PCI • LM+multivessle diseases ---- CABG
LM-PCI: Basic and Logistic Surports • Experienced & skilled operators • Procedural strategy in advance • Emergency therapeutic measures in advance • IABP for high risk Pts(EF<35%) • Cardiac surgery stand by • IVUS available • CCU available
LM-PCI: Considerations for Decision Making • LVF • LM lesion • LM with or without multi-vessle disease • Duel anti-platelet therapy durability • Operaters skills & experiences • Evaluation the risk of PCI vs CABG • Follow-up CAG necessary
LM Bifurcation PCI: Strategic Considerations Based on Lesion Anatomy • Size of LM ,LAD & LCX • LCX ostium lesion • The angle beteen LCX & LM • The angle beteen LAD& LM
LM Kissing Stenting: Tenchniques • TFI: classic kissing Guiding catheters: 8Fr. EBU Wires: double wires, BMW Pilot 50 etal. Balloon: 2.5-3.0mm predilatation • TRI: step kissing stenting Guiding: 6Fr. EBU(ID: 0.071”)AL1-2 Wires: double wires, it depends Balloon: 2.5-3.0mm
Classic LM Kissing Stenting: Procedural Skills • IABP if eeded • No damping of ABP after guiding engagement • Double wiring • Selection of stents in advance • Predilatation with moderate pressure • Two stents advanced sequentially • Keep proximal end of two stents at a line
Deploy the two stents sequentially(no simaltaneously)with high presure • Final kissing with balloon in place is manditory • Rekissing with the two balloon out of proximal end of stents is also necessery • IVUS ckeck • Post kissing dilatation if needed
Step LM KIssing Stenting: Procedural Skills • IABP through femeral rout if needed • TRI • Guiding: 6Fr giant lumen EBU or AL1-2 • Wires: double wiring • Balloon: Predilatation the most severe lesion first • One stenting: advance stent distal to the lesion with a balloon followed in another vessel at LM bifurcation
Alighment: two proximal ends of stent & balloon alighed and positioned at LM • Stent deployment and kissing, the proximal rekissing • Second stenting: advance another stent distal to the lesion with a balloon(same size as stent)in the stent • Alighment of the proximal end of stent & balloon, stenting, kissing & Proximal rekissing • IVUS ckeck • Post kissing dilatation if needed
LM – Bifurcation: Case 1 • High risk LM - IABP • 78yrs male with repeat MI and HF • during last 3yrs • Angulated LM bifurcation lesion: • one-stent crossover+balloon kising • technique
78yrs male with repeat MI and HF during last 3yrs Angulated LM bifurcation lesion: one-stent crossover+balloon kising technique
LM Bifurcation: Case 2 • Two-stent technique: step crush stenting