1. 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

2. 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

3. 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

4. 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

5. 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

6. Numbers of PCI @ Fu Wai Each Year 80.22% in 2007

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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.

14. 71% enrolled (N=3,075) 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%) TAXUS n=903 PCI n=198 CABG n=1077 CABG n=897 no f/u n=428 5yr f/u n=649 PCI all captured w/ follow up CABG 2500 750 w/ f/u vs Total enrollment N=3075 Stratification: LM and Diabetes Two Registry Arms Randomized Arms n=1800 Two Registry Arms N=1275 Randomized Arms N=1800 Heart Team (surgeon & interventionalist) PCI N=198 CABG N=1077 Amenable for only one treatment approach TAXUS * N=903 CABG N=897 vs Amenable for both treatment options Stratification: LM and Diabetes LM 33.7% 3VD 66.3% LM 34.6% 3VD 65.4% DM 28.5% Non DM 71.5% NonDM 71.8% DM 28.2% 23 US Sites62 EU Sites + SYNTAX Trial Design

15. 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 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 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 Tortuosity Thrombus Bifurcation Total Occlusion 3 Vessel Left Main Dominance Calcification Number & location of lesions SYNTAX score

16. Adverse Events to 12 Months ITT population Event Rate ± 1.5 SE, * Fisher exact test All Death Revascularization CVA (Stroke) Myocardial Infarction TAXUS* (N=903) CABG (N=897)

17. Revascularization * to 12 Months Left Main Subset 6.7% 12.0% 0612 20 40 0 Months Since Allocation Cumulative Event Rate (%) P=0.02 * TAXUS (N=357) CABG (N=348) Event rate ± 1.5 SE, * Fisher exact test * Any revascularization (PCI or CABG); ITT population

18. MACCE to 12 Months Left Main Subset P=0.44 * 0612 20 40 0 Months Since Allocation Cumulative Event Rate (%) 13.6% 15.8% TAXUS (N=357) CABG (N=348) Event rate ± 1.5 SE, * Fisher exact testITT population

19. 0612 20 40 0 Months Since Allocation Cumulative Event Rate (%) TAXUS (N=118) CABG (N=103) P=0.19 * 7.7% 13.0% Event rate ± 1.5 SE, * Fisher exact testCalculated by core laboratory; ITT population MACCE to 12 Months by SYNTAX Score Tertile Low Scores (0-22) LM Subset Mean baseline SYNTAX Score CABG15.5 ± 4.3 TAXUS15.7 ± 4.4

20. 0612 20 40 0 Months Since Allocation Cumulative Event Rate (%) TAXUS (N=195) CABG (N=92) Event rate ± 1.5 SE, * Fisher exact testCalculated by core laboratory; ITT population P=0.54 * 15.5% 12.6% MACCE to 12 Months by SYNTAX Score Tertile Intermediate Scores (23-32) LM Subset Mean baseline SYNTAX Score CABG27.2 ± 3.0 TAXUS27.0 ± 2.7

21. 0612 20 40 0 Months Since Allocation Cumulative Event Rate (%) TAXUS (N=135) CABG (N=150) P=0.008 * 25.3% 12.9% Event rate ± 1.5 SE, * Fisher exact testCalculated by core laboratory; ITT population MACCE to 12 Months by SYNTAX Score Tertile High Scores (  33) Left Main Subset Mean baseline SYNTAX Score CABG42.1 ± 7.6 TAXUS43.8 ± 9.1

22. Overall MACCE at 12 Months Left Main Subset ITT population TAXUS CABG (n=705)(n=91)(n=138)(n=218)(n=258) P=0.44P=1.0P=0.27P=0.29P=0.42 Patients (%)

23. LM PCI----High Risk ！

24. 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

25. 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

26. 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

27. 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

29. 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” ） AL 1-2 Wires: double wires, it depends Balloon: 2.5-3.0mm

30. 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

31. 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

32. Step LM KIssing Stenting: Procedural Skills IABP through femeral rout if needed TRI Guiding: 6Fr giant lumen EBU or AL 1-2 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

33. 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

34. 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

35. 78yrs male with repeat MI and HF during last 3yrs Angulated LM bifurcation lesion: one-stent crossover+balloon kising technique

47. LM Bifurcation: Case 2 Two-stent technique: step crush stenting

48. LM bifurcation: step crush stenting

52. 肖红兵 M 61yrs Inverse crush Excel Stents LAD: 3.5×14mm LCX: 3.5×18mm LM Bifurcation: Case 3

53. RCA stent OK （ 1 week ago ） LM bifurcation stenosis of 80-90% LCX-OM 90% LAD-Ostium 90% LCX-Ostium 80-90% LM bifurcation 80%

54. Ballooning & stenting of LCX-OM

55. Post-stenting of OM

56. Ballooning & stenting of LAD-LM

57. Ballooning & stenting of LCX-LM and crushing over LAD stent

58. Post-double stenting LM bifurcation

59. Rewing, reballooning and post-dilatation of LM- LAD stent

60. Post-dilatationing LM-LCX stent and final kissing double stenting of LM bifurcation

61. The final results

62. IVUS check optimal results LAD-LM Proximal LAD & distal seg of stent; distal stent: fully expanded; at the LM bifurcation ; LM stent: fully expanded & No in complete apposition; Proximal LM

63. IVUS check optimal results LCX-LM Proximal LCX stent: fully expanded; at the LM bifurcation; distal LM stent; Proximal LM stent.

64. LM Bifurcation: Case 4--8 Kissing stent---TFI Step kissing stent---TRI

65. TFI ： classic LM Bifurcation kissng Stenting

68. LM Bifurcation: Case 5 Kissing stent---TFI

77. Step kissing with TRI （ 08-1-28): 刘忠 M 40yrs 病案号： 647737 STEMI×3weeks Primary PCI failure Big LM+ Bifurcation ： 80 ％ with Both LAD & LCX Ostium: 90 ％ Mid-RCA: 50 ％ IABP support IVUS check LM Bifurcation: Case 6

78. Baseline CAA Big LM, Bifurcation 80% with LAD & LCX ostium both 90% RCA Normal

79. Pre-dilatation & step kissing Two wires pretection, Pre-dilatation of LAD （ 16atm ） Pre-dilatation of LCX, LCX: liberte 3.5×16mm （ 16atm ）, LAD: 3.0mm balloonballooning, first proximal kissing.

80. Pre-dilatation & step kissing LAD stenting （ lib 3.5×20 ）, LCX ballooning （ quant 3.5×15 ） Kissing & proximal stents rekissing, post stents kissing

81. Big balloon kissing Post dilatation （ 20atm ） : LAD （ quant 4.5×15 ）, LCX （ quant 4.0×15 ） final kissing （ 20atm ） proximal stent kissing （ 20atm ）

82. Final results

83. IVUS Check: LCX Distal LCX, LCX stent, Ostium LCX LM within stent, LM out of stent

84. IVUS Check: LAD Distal LAD, distal stent, proximal stent, Ostum LAD stent LM within stent, LM out of stent

85. LM Bifurcation Step Kissing: 1 yrs Follow-up CAA （ 09-2-12 ）

86. LM Bifurcation: Case 7 Step-Kissing Stenting 男性， 65 岁 高血压 糖尿病 高脂血症 陈旧性心肌梗死

87. LM Step kissingstenting

89. AL2.0, Pilot150, BMW Maverick 1.5x15mm, 2.5x15mm

90. LAD: Maverick 3.0x20mm LAD :Taxus Liberte 3.5x24mm LCX: Maverick 3.0x15mm

91. LAD :Quantum Maverick 3.5x15mm LCX: Taxus 3.0x24mm

94. LM Bifurcation: Case 8 Step Kissing stenting 苏润平 M 41yrs 678194

98. IVUS RAMUS-LM

99. IVUS LAD-LM

100. TRI for LM Bifurcation stenting: High Risk for Complications! Step kissing stent step crush Stent dislodgement Oustium even aortic root dissection Procedural failure due to wiring failure Side branch acute closure

101. LM 分叉病变并发 LAD 急性闭塞 王继川 M 56yrs 663049 LM body 90% LM-LAD rectangular angulated LM-LCX rectangular angulated LM-LCX Crossover stenting complicating LAD acute closure High Risk, No IABP IABP+NTG: TIMI Ⅰ — Ⅱ级！ Currott Stenting

102. Baseline CAA

103. LM-LCX Crossover Stenting （ 4.5×16mm ） Complicating LAD Acute Closure

106. 刘焕清 M 68yrs 病案号： 657990 TRI LM 分叉 Kissing stenting 失败（ IVUS ） Crush 成功（ IVUS ） PCI:08-6-12

118. Step kiss Stenting complicating Stent Crushing LAD-LM with stent out of two crushed stents

119. within stent within stent crushing the other one LM Dissected LCX-LM

120. LM-LCX within stent out of two crushed stent with stent crushing the other stent

121. LM Stent Dislodgement （ 5.0×16mm ） 胡群英 M 63yrs 667883 LM 90 ％ Stent dislodgement

126. IVUS

127. Step Kissing for LM Bifurcation Lesion Complicating Dissection Involving Aortic Root 葛景新 M 66yrs 653726 LM bifurcation Step kissing stent

128. Baseline CAA & Step Kissing Stent

132. IVUS OK

133. 马晓峰 M 52yrs 636885 OMI （ IPW ） for 3 weeks 07-9-13 baseline CAA: LM Bifuro 80-90% LAD Orifice 90% Mid-seg 80% LCX Orifice 70% & bifurcation RCA Mid-seg: 70-80% PDA （ IRA ） Mid-seg: 100% LVG: hypokinesia in inferior wall

134. Mid-LAD 80% 3 sep-big-suppiying PDA collateral LM Bifurcation 90% with LAD orifice 90% more LCX 80% with bifurcation

135. Mid-RCA 80% Mid-PDA （ IRA ） 100% ED-WG ES-WG Severe hypokinesia in Mid Inferior wall

136. Mid-RCA 80% PDA 100% Predilatation PDA 2.5×18mm 支架 3.5×33mm 支架 IHF 2007 live demonstration （ 07-9-22 ）

137. LM-Bifurcation PCI TFI-8F EBU 3.5 guiding Big LM with bifurcation sever stenosis and without sever calcification Big sep to PDA collateral disappeared

138. Wiring to LCX-OM & LAD With 2.5mm balloon predilatation of LAD lesion appearing augulation LM-LAD lesion not fully opened

139. Cypher 、 endeavor stenting could not cross the LM-LAD augulated lesion resulting in acute dosure, IABP was inserted as needed Kissing predilatation intimal teared

140. Kissing stent with liberte 3.5×24mm in LAD & 2.75×18mm in LCX final kissing successful but LAD distal to stent Severe disected another two stenting deploded in Mid-LAD

141. Big septum OK Kissing stenting successful

142. Post-dilatation & kissing final results better final results

143. Conclusions or Warning! Coronary LM disease: routine PCI ? No, it depends on – Patient’s condition, intention, ecnomic situation & family member’s agreement – Doctor’s experience, skill & qualitications – Risk stratificalions: never do it for the high risk patients （ Cardiac noncardiac ）

144. Cardiac Surgeon’s Consuilt Right strategies technique skill & feasibility Circulation surpport measurea it needed Postoperative intensive care （ CCU ） Remember: almost all LM disease itself is high risk!

145. TFI 的存在问题（一） 自身局限性：桡动脉细小 穿刺易失败：应精细 易痉挛：改股动脉（ 5 进 6 ？） 解剖变异：食道后：不可能（ JR4 引导） 极度弯曲：操作困难（ 5 进 6 ？） 球囊的限制：后扩 支架的限制：双支架

146. TFI 的存在问题（二） 操作问题：应尽量避免 – 穿刺不熟练：诱发桡动脉痉挛 – 超滑导丝操作过猛：血管损伤，血肿，骨筋膜 挤压综合症 – 引导导管前送过粗：诱发血管痉挛和损伤 – 引导导管选择失误：管腔和后坐力不够 – 支架选择失误：双支架植入失败 – 后扩球囊选择失误： Kissing 技术不能

147. 我国 TRI 技术发展方向 首先开始做 操作精细：绣花？ 培训，实践，经验积累 开创新技术，规范，交流 攻克技术难关：痉挛、迂曲、变异 建立 TRI 微创新模式 普及，提高，全面推广！ TRI 时代已经到来！ 让我们共同努力！

148. 欢迎参加 2009 北京国际心血管论坛 (IHF2009) ： 第一届国际 TRI 手术演示大会 2009/09/11 － 13 ，北京

150. 150 Unit of measure