Do We Need a Mega RCT Comparing TFI vs TRI in China?

Yuejin Yang MD, PhD, FACC

Cardiovascular Institute and Fu-

Wai Hopital, CAMS & PUMC

CIT 2010, Mar.31-April.3,2010, Beijing, China

PCI Approaches

• Trans-femoral (classic)

• Trans-radial (popular)

• Trans-ulnar (alternative)

• Trans-formal (last choice)

The Shortcomings of TFI• Forceful lying on bed ： undurable for patients

high risk of death for induced PE ！• Complications at puncture site ： bleeding and hemotoma

also high risk of death due to

postperitoneal bleeding ！• Occlude device ： cost more

unable to use the vessel shortly

The Advantages of TRI• Transradial: mini-invasive no risk of post-peritoneal hemorhegic death ！• Free mobile postprocedure : unpainful for patients no risk of death induced by DVT+PE ！ less clinical & nurse care work • Short hospital stay ： cost less

Technically Feasible in TRI

• The majority of TFI is routinely performed

with 6Fr guiding.

• The size of radial artery in the majority of

Chinese adults also fits with 6Fr guiding.

• TRI is actually as same as TFI with 6Fr

guiding.

• Routine TRI is as possible as TFI in daily

practice with 6Fr guiding.

Pioneer in TRI• Dr. Campeau (Canada) TRA (angiogram) (1989)• Dr. Kiemeneiji(The Netherland) TRI (1992)• French Drs: Louvard Y practice of TRI Morice M improverent of devices Fajadet J 5Fr. guiding use Hamon M CARAFE Study etc.• Dr. Saito Sh. (Japan): Live Demon at TCT for complex lesions for AMI Pts• Others : ……

TRI Development in China

• With the help of Drs: Saito, Kiemeneiji, Hamon,etc.• Initiation stage (1996-1999)

In ChaoYang ,You yi by Dr. Saito in 1996 In Fu-Wai hosp. by ourselves in 1997

Followed by some Drs. Centers, with some cases• Expansion stage (2000-2005)

Headed by FuWai, Friendship, and AnZhen Hosps.

HeBei, Harbin, Zhijiang univ. Hosp.

and more headed Hosp.

More and more Drs, Centers and cases

involved and performed.

Prevailing and upgrading stage （ 2006—2010 ） In 163 Centers with 48% ( 51984/108658)

CAA and 45 ％ (20189/45176 )PCI cases

were performed with PCI in 2006 (Dr Wang )

Much more expansion in quantity of Drs

centers & cases

Much more upgrade in qualityCJC ， 2007 （ 35 ）： 806 － 809CJC ， 2007 （ 35 ）： 806 － 809

Current Status of TRI in China

• About 10 yrs experience accumulated

• Technically matured ： as mature as TFI

• The sites and interventioners well

expanded

Almost all the complex procedures used

in TFI can currently be performed in TR

• Advanced and leading level in the world in some complicated procedures

TRI Widely Used in China

In 2007, ＞ 60% (69354/115142) CAA and >56%

(27227/48379) PCI cases were performed with

TR approach in China.

Almost all CAA and ＞ 80% PCI cases in Fuwai

hospital as well as some other hospitals

As some centers in Europe, Canada, Japan

and other Asia contires

Wang L, etel. CJC: 2009Wang L, etel. CJC: 2009

TRI in Fu-Wai hospital• Rapid development in skills:

Began in 1997,

Matured in 2003

Routine practice since 2004• The largest TRI training center

TRI first choice for any lesions

All the 20 Drs. doing PCI with TRI

All the 200 fellows yearly training in TRI

>85% TRI （ 2659/3821 ） and in 2009• For both simple and complex cases.

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

Fu-Wai H: TRI Training Center• Rapid development in skills:

Began in 1997,

Matured in 2003

Routine practice since 2004• The largest TRI training center

All the 20 Drs. doing PCI with TRI

All the 200 fellows yearly training

in TRI

> 85% (4326/5148) TRI in 2009• For more complicated cases.

New PCI Techniques Currently Used for Complicated Lesions

For CTO: final stronghold antigrade approach retrograde approach

For LM: high risk one stent techniques

two stent For bifurcation: complicated

One stent techniqueTwo stent techniques

DK crush Cullotte SKSProvisional T TAP

New PCI Techniques Can Currently be Performed with TRI

For CTO: anti-grade approach retro-grade approach

For LM: one-stent technique two-stent techniques

For bifurcation: one-stent technique

two-stent techniques step DK crush reverse crush step cullotte kissing stent Provisional T TAP

Key Skills for Successful TRI• Accurate radial A puncturing for successful

cannulation

• Gentle catheter forwarding and manipulating

to avoid initiating radial A spasm

• Unique guiding catheter manipulating for

coronary ostium engaging.

• Special guiding catheter choosing to get

enough backup support

Principles For Guiding Catheter

Selection in TRI• RCA :6F-JR4(80%). Amplatz L1 or XB-RCA (20%)

• LAD :6F-JFL. EBU-3.5 、 XB-3.5 、 Amplatz L1

(>90%) and JL3.5 (10%)

• LCX and CTO, long diffuse ,bifurcation, tortuous

and angutating lesions (100%) :6F -JFL. EBU-3.5 、XB-3.5 、 Amplatz L1

• Kissing and crushing technique :6F-Luncher

(larger lumen, ID0.071”)guiding catheter

TRI for CTO Lesions?

Possibilifies PCI bases TRI skills CTO techniques

Key elements Guiding back-up support Wire manipulation for penetrating to true lumen Balloon crossing and dilatation Stenting

CTO: Three Key Elements

Guiding catheter: strong back-up support

Essential

Wire: Get through lesion

Pivotal role

Balloon: Cross the lesion

Also important

Sometimes be problematic with TRI ?

CTO: Key Techniques

Specialized wires （ above ） Dual （ contralateral ） injection

Parallel wire and see-saw technique

Lumen reentry （ STAR, CART ） IVUS guidance

Tornus catheter

Retrograde （ collateral ） approach

Novel devices: Safe Cross, Frontrunner, Crosser

RCA CTO with SVG occluded after 3 years of CABG

彭世英 F 61 岁 病案号： 606891

CHD 4 年 CABG 2 年 症状再发 1 年TFI ： 5Fr 导管 SVG-LAD 引导TRI ： AL1-RCA

CAA ： SVG-RCA 100%

SVG-LAD OK

LM OK LAD 100%

LCX 100% RCA 100%

IVUS ： Perfect

CAA: 2008-4-28

EUROPCR 2008 Life DEMO case (2008-5-16)

LM and/or 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

Shi JF F 64yrs

病案号： 692169 09-8-24

• CABG for 3 months

• LIMA 100%,

• SVG-LCX 100%

• LM bifurcation: 90%

• Crush technique used

• IVUS checked

• Follow-up CAA(io-1-20)

• SVG-RCA: patent

Baseline CAA+PCI(crush)(09-8-24)

Follow-up CAA(2010-1-20)

刘忠 M 40yrs

647737

STEMI×3weeks

Primary PCI failure

TRI （ 08-1-28 ）IABP support

LM bifurcation with step kissing

IVUS check

Follow up CAA (09-2-12)

baseline

LM OK, LAD ostium 90% LCX ostium 90%RCA Normal

Pro-dilatation & step kissing

two wires pretection, Pro-dilatation of LAD （ 16atm ）Pro-LCX Pro-dilatation LCX: liberte

3.5×16mm （ 16atm ） LAD: 30mm balloonLAD ballooning first proximal kissing

Pro-dilatation & step kissing

LAD stenting （ liberte 3.5×20mm, 16atm ） LCX balloon （ quantum 3.5×15mm ）

Kissing proximal stents rekissing post kiss stents

big balloon kissing

LAD post dilatation （ quantum 4.5×15mm ） LCX （ quantum 4.0×15mm ）

LCX pos dilatation （ 20atm ） final kissing （ 20atm ） proximal stent kissing （ 20atm ）

Final results

LCX

Distal LCX, LCX stent, Ostum LCX

LM with in stent, LM out of stent

LAD

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

LM with in stent, LM out of stent

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

Conclusions• With TRI not only simple lesions and cases

can be performed

• But also complex and high risk ones

• TRI can be as routine as TFI in daily practice

• It’s time to organize a large scale, multicenter,

randomized clinical trial, or large scale

multicenter registry in China, to verify the

advantages of TRI over TFI.

• Thank you very much for your all attention!

• Special thanks to our distinguished TRI pioneer Dr. Saito for his generous and continuous help and support in initiating and rapid spreading TRI technology in China !

Welcome Attend China Heart Conference (IHF2010) ：

2nd international TR Coronary Therapeutics (TRCT)

Chaired byYue-Jin Yang MD. PhD. FACC

Co-Chaired byDr. Saito

Dr. kiemeneijiNCC, 2010/08/13-15, Beijing, China

Thank you very much !