经桡动脉治疗 LM 分叉病变

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

415 618921

1386 16051967

2555

32823821

4778

3 3 13 186 374706

1247

20182659

3833

0

1000

2000

3000

4000

5000

6000

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Total PCI Radi al

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 approachretro-grade approach

For LM:one-stent techniquetwo-stent techniques for LM

bifurcation For bifurcation:

one-stent techniquetwo-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.

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=903PCI

n=198CABG

n=1077CABGn=897

no f/un=428

5yr f/un=649

PCIall captured w/

follow up

CABG2500

750 w/ f/uvsvs

Total enrollment N=3075

Stratification: LM and Diabetes

Two Registry ArmsRandomized Armsn=1800

Two Registry ArmsN=1275

Randomized ArmsN=1800

Heart Team (surgeon & interventionalist)

PCIN=198

CABGN=1077

Amenable for only one treatment approach

TAXUS*

N=903 CABG

N=897vsvs

Amenable for bothtreatment options

Stratification: LM and Diabetes

LM33.7%

3VD66.3%

LM34.6%

3VD65.4%

DM 28.5%

Non DM71.5%

NonDM71.8%

DM28.2%

23 US Sites62 EU Sites +

SYNTAX Trial DesignSYNTAX Trial Design

Patient ProfilingPatient 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;1:219-227Valgimigli et al, Am J Cardiol 2007;99:1072-1081Serruys et al, EuroIntervention 2007;3:450-459Coronary 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;63:285-299Lesions classification ACC/AHA , Circ 2001;103:3019-3041Bifurcation classification, CCI 2000;49:274-283CTO classification, J Am Coll Cardiol 1997;30:649-656

Tortuosity

Thrombus

Bifurcation

Total Occlusion

3 Vessel

Left Main

Dominance

Calcification

Number & location

of lesions

SYNTAXscore

Adverse Events to 12 Months

ITT populationEvent Rate ± 1.5 SE, *Fisher exact test

All Death

Revascularization

CVA (Stroke)

Myocardial Infarction

TAXUS* (N=903)CABG (N=897)

Revascularization* to 12 Months

Left Main Subset

6.7%

12.0%

0 6 12

20

40

0

Months Since Allocation

Cu

mu

lati

ve E

ven

t R

ate

(%

)

P=0.02*

TAXUS (N=357)CABG (N=348)

Event rate ± 1.5 SE, *Fisher exact test *Any revascularization (PCI or CABG); ITT population

MACCE to 12 MonthsLeft Main Subset

P=0.44*

0 6 12

20

40

0


Cu

mu

lati

ve E

ven

t R

ate

(%

)

13.6% 15.8%


Event rate ± 1.5 SE, *Fisher exact test ITT population

0 6 12

20

40

0


Cu

mu

lati

ve E

ven

t R

ate

(%

)


P=0.19*

7.7%

13.0%

Event rate ± 1.5 SE, *Fisher exact test Calculated by core laboratory; ITT population

MACCE to 12 Months by SYNTAX Score Tertile

Low Scores (0-22) LM Subset

Mean baselineSYNTAX Score

CABG 15.5 ± 4.3

TAXUS 15.7 ± 4.4

0 6 12

20

40

0


Cu

mu

lati

ve E

ven

t R

ate

(%

)



P=0.54*

15.5%12.6

%


Intermediate Scores (23-32) LM Subset


CABG 27.2 ± 3.0

TAXUS 27.0 ± 2.7

0 6 12

20

40

0


Cu

mu

lati

ve E

ven

t R

ate

(%

)


P=0.008*

25.3%

12.9%



High Scores (33) Left Main Subset


CABG 42.1 ± 7.6

TAXUS 43.8 ± 9.1

Overall MACCE at 12 MonthsLeft Main Subset

ITT population

8.5

13.2

15.8

19.8 19.3

13.715.4

14.4

7.57.1

0

5

10

15

20

25

LM all LM only LM+1VD LM+2VD LM+3VD

TAXUSCABG

(n=705) (n=91) (n=138) (n=218) (n=258)

P=0.44 P=1.0 P=0.27 P=0.29 P=0.42

Pati

en

ts

(%)

LM PCI----High Risk ！

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

• 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

LM bifurcation: step crush stenting

肖红兵 M 61yrs

Inverse crush

Excel Stents LAD: 3.5×14mm

LCX: 3.5×18mm

LM Bifurcation: Case 3LM Bifurcation: Case 3

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%

Ballooning & stenting of LCX-OM

Post-stenting of OM

Ballooning & stenting of LAD-LM

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

Post-double stenting LM bifurcation

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

Post-dilatationing LM-LCX stent and final kissing

double stenting of LM bifurcation

The final results

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

IVUS check optimal results

LCX-LM

Proximal LCX stent: fully expanded;

at the LM bifurcation; distal LM stent; Proximal LM stent.

LM Bifurcation: Case 4--8

• Kissing stent---TFI• Step kissing stent---TRI

TFI ： classic LM

Bifurcation kissng

Stenting


• Kissing stent---TFI

• 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 6LM Bifurcation: Case 6

Baseline CAA

Big LM , Bifurcation 80% with LAD & LCX ostium both 90% RCA Normal

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.

Pre-dilatation & step kissing

LAD stenting （ lib 3.5×20 ） , LCX ballooning （ quant 3.5×15 ）

Kissing & proximal stents rekissing , post stents kissing

Big balloon kissing

Post dilatation （ 20atm ） : LAD （ quant 4.5×15 ） , LCX （ quant 4.0×15 ）

final kissing （ 20atm ） proximal stent kissing （ 20atm ）

Final results

IVUS Check: LCX

Distal LCX, LCX stent, Ostium LCX

LM within stent, LM out of stent

IVUS Check: LAD

Distal LAD, distal stent, proximal stent, Ostum LAD stent

LM within stent, LM out of stent

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


• Step-Kissing

Stenting

• 男性， 65 岁

• 高血压

• 糖尿病

• 高脂血症

• 陈旧性心肌梗死

LM Step kissingstenting

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

LAD: Maverick 3.0x20mm LAD :Taxus Liberte 3.5x24mmLCX: Maverick 3.0x15mm

LAD :Quantum Maverick 3.5x15mm

LCX: Taxus 3.0x24mm


• Step Kissing stenting

• 苏润平 M 41yrs 678194

IVUS RAMUS-LM

IVUS LAD-LM

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

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: TIMIⅠ—Ⅱ 级！Currott Stenting

Baseline CAA

LM-LCX Crossover Stenting（ 4.5×16mm ） Complicating

LAD Acute Closure

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

Step kiss Stenting complicating Stent Crushing

LAD-LM

with stent out of two crushed stents

within stent within stent crushing the other oneLM Dissected

LCX-LM

LM-LCX

within stent out of two crushed stentwith stent crushing the other stent

LM Stent Dislodgement （ 5.0×16mm ）

胡群英 M 63yrs 667883

LM 90 ％

Stent dislodgement

IVUS

Step Kissing for LM Bifurcation Lesion Complicating Dissection

Involving Aortic Root

葛景新 M 66yrs

653726

LM bifurcation

Step kissing stent

Baseline CAA & Step Kissing Stent

IVUS OK

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

Mid-LAD 80% 3 sep-big-suppiying PDA collateral

LM Bifurcation 90% with LAD orifice 90% more LCX 80% with bifurcation

Mid-RCA 80% Mid-PDA （ IRA ） 100%

ED-WG ES-WG Severe hypokinesia in Mid Inferior wall

Mid-RCA 80% PDA 100%Predilatation PDA 2.5×18mm 支架 3.5×33mm 支架

IHF 2007 live demonstration （ 07-9-22 ）

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

Wiring to LCX-OM & LADWith 2.5mm balloon predilatation of LAD lesion

appearing augulationLM-LAD lesion not fully opened

Cypher 、 endeavor stenting could not cross the LM-LAD augulated lesion resulting in acute dosure, IABP

was inserted as needed

Kissing predilatation intimal teared

Kissing stent with liberte 3.5×24mm in LAD & 2.75×18mm in LCXfinal kissing successful but LAD distal to stent

Severe disectedanother two stenting deploded in Mid-LAD

Big septum OK

Kissing stenting successful

Post-dilatation & kissing finalresults better final results

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 ）

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!

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

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

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！

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

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经桡动脉治疗 LM 分叉病变