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 ( ) 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 ( ) 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 quality CJC ， 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: 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 Fu Wai Each Year 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 technique Two stent techniques DK crush Cullotte SKS Provisional 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： CHD 4 年 CABG 2 年 症状再发 1 年 TFI ： 5Fr 导管 SVG-LAD 引导 TRI ： AL 1 -RCA CAA ： SVG-RCA 100% SVG-LAD OK LM OK LAD 100% LCX 100% RCA 100% IVUS ： Perfect

CAA:

EUROPCR 2008 Life DEMO case ( )

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： 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)( )

Follow-up CAA( )

刘忠 M 40yrs STEMI×3weeks Primary PCI failure TRI （ ） IABP support LM bifurcation with step kissing IVUS check Follow up CAA ( )

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 balloon LAD 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 （ ）

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 by Yue-Jin Yang MD. PhD. FACC Co-Chaired by Dr. Saito Dr. kiemeneiji NCC, 2010/08/13-15, Beijing, China

Thank you very much !