do we need a mega rct comparing tfi vs tri in china? yuejin yang md, phd, facc cardiovascular...
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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 !