Slender Club Japan (SCJ) is an organization that advises Japanese companies on developing slender cardiac devices. They have contributed to the development of the Ikari guiding catheter, 0.010 inch systems, sheathless systems, Glidesheath slender, and a 6F intra-aortic balloon pump (IABP). The presentation discusses the Ikari L guiding catheter concept and its advantages over other catheters for transradial interventions. It also evaluates the feasibility of using a 6F IABP via the brachial artery, finding lower bleeding risks but some limitations like lack of pressure monitoring and limited balloon capacity.
1. Brachial IABP to Support
Complex Transradial PCI and
Slender Club Japan
Yuji Ikari, MD
Department of Cardiology
Tokai University School of Medicine,
Japan
Stuttgart 2017
3. Slender Club Japan (SCJ)
• SCJ is organized by the Three
Musketeers.
• SCJ has developed new slender
techniques
– Emperor’s new clothes
– Chameleon
• SCJ has advised Japanese
companies to develop new slender
devices.
4. Slender Devices
• Ikari guiding catheter
• 0.010 inch system
• Sheathless system
• Glidesheath slender
• 6F IABP
• And others
5. Now, many types of Ikari L are available.
Terumo
Heartrail2
Asahi Intech
Hyperion
Goodman
Profit
Medtronics
Launcher
7. Hypothesis; physics of backup force
• Fcosq =k(fcosq’ + l)
• fcosq ’ + l
Fmax = k ―――――
cosq
Maximum backup force is
acheved if
q=90 degree; q’= 0
degree; or l is large.
q’ q
l
Ikari et al. J Invasive Cardiol 2005 ;17:636-41
8. Judkins L can generate greater
backup force in TFI than in TRI.
θr
A
θf
B
0
10
20
30
40
50
60
70
TRI TFI
resistance(gramforce)
P<0.05
Ikari et al. J Invasive Cardiol 2005 ;17:636-41
9. Deep engagement increases
backup force in Judkins L
θ4 θ4deep
0
10
20
30
40
50
60
JL4.0 JL4.0 Deep
resistance(gramforce)
P<0.05
Ikari et al. J Invasive Cardiol 2005 ;17:636-41
13. TRI for Right Coronary Artery
Amplatz L Ikari L Judkins R Ikari L
With 035 inch GW
14. Angiography by Ikari-L 3.5
6Fr
N = 621
Ad hoc PCI
N =380 (61.2%)
Primary endpoint
Device efficacy
Device safety
Secondary
endpoint
Procedural success
Engagement rate
Procedure time
Fluoroscopy time
Contrast volume
EuroInterv. 2007; 3: 475-481.
Engagement rate
RCA 609(98.1%)
LCA 617(99.4%)
15. STEMI: ST elevation in II, III, aVF
Primary PCI was tried in another hospital
16. They tried TRI using a 6F Amplatz Left 1.
A guidewire passed the lesion but a balloon
could not. They failed PCI despite 3 hours
procedure.
Final
17. The patient transferred to our hospital.
A young doctor successfully performed POBA
using a 7F Ikari L and anchor balloon technique.
TIMI 3 flow was achieved.
18. I performed PCI using a 6F Ikari L without any
techniques such as anchor balloon.
Power position of Ikari L
19. Comparison in TRI
JR IR AL IL
0
20
40
60
80
100
120
140
160
JR4 IR1.5 AL1 IL3.5
maxresistance(gforce)
20. New Concept of Ikari L for STEMI
• TRI for STEMI Improves
Mortality
• Shorter D2B time is
necessary
• If Ikari L is used you can
shorten reperfusion time
21. Primary PCI for STEMI
1) Radial artery puncture
2) Insertion of diagnostic catheter (L)
3) Engagement of diagnostic catheter (L) for LCA
4) Angiography of LCA
5) Removal of the catheter (L)
6) Insertion of diagnostic catheter (R)
7) Engagmennt of diagnostic catheter (R) for RCA
8) Angiography of RCA
9) Removal of the catheter (R)
10) Insertion of a guiding catheter
11) Engagement of the guiding catheter
12) Guidewire passage
13) First device activation (balloon or thrombus aspiration)=Reperfusion
Catheter insertion 3 → 1
Catheter removal 2 → 0
Engagement 3 → 2
22. Puncture to Balloon time
10 (7-12)min 17 (13-23) min
p=0.001
IL
group
Conventional
group
min
Cardiovasc Interv and Ther
DOI 10.1007/s12928-016-0395-z
23. Tip Entry Profile: 0.014-inch 0.012-inch
(0.36 mm 0.31 mm)
OLD NEW
0.0120.014
0.010
24. Ikazuchi X balloon
Possible to insert
2 balloons and 2 wires
together within the
5Fr guiding catheter
3 balloons and 3 wires
together within the
6Fr guiding catheter
25. 5Fr KBT
Yoshimachi F, Masutani M, Matsukage T, et al.
J Invasive Cardiol 2007;19:519–524
6Fr KGT
Matsukage T, Masuda N, Ikari Y
J Invasive Cardiol 2008;20:E210–214
Available in the Small-lumen Guiding Catheter
26. Initial IKAZUCHI-X crossing 147 / 147 (100)
Requirement of 0.014-inch guidewire 9 / 148 (6.1)
To pass a CTO lesion 1
To deliver a STENT system 8
Clinical success (for cases) 132 / 133 (99.2)
Device success (for lesions) 147 / 148 (99.3)
Registry study for routine use of 0.010 system
Including 25 CTO lesions
A 010 Balloon is good.
However, there is a limitation in 010 guidewires.
27. 3 Fr Sheath O.D. Sheathless 5 Fr G.C
1.70 mm 1.71 mm
3 5
0.059 inch 0.059 inch
≒
A 5F Guiding catheter is used without a sheath,
It is equal to 3F sheath size.
39. Virtual 1F=19G needle size
Terumo gave up sales because manufacturing
cost was higher than sales cost
40. Thinner sheath wall thickness to
make outer diameter smaller
*Intended to use only radial approach
Design Concept
41. 3 size variation to improve daily TRI practice
5Fr
Less invasiveness
6Fr
Daily Practice
7Fr
Complex PCI
Size variation
42. Slender IABP
• 6F IABP system (Zeon Medical)
• Compatible GW is 0.014 inch
– Impossible to monitor arterial pressure
• Only 30 ml type
• Catheter length is short
– 777mm
0.017inch
50. Limitations (Device)
Guidewire 0.014 compatible
Balloon volume is ONLY 30ml.
IABP tip pressure is NOT available.
Trans-Brachial insertion is Off Label use.
In case of draw-back of the IABP catheter,
it may cause injury on subclavian artery.
52. Summary : 6F IABP
The 6-Fr IABP system was feasible in
clinical use with lower bleeding
complications.
However, TB-IABP has several critical
limitations such as no blood pressure
monitoring, potential risk for subclavian
artery or more time necessary for the
procedure due to less support of 0.014
inch GW.
53. Slender Club Japan has advised Japanese
companies on development of slender
devices
• Ikari guiding catheter
• 0.010 inch system
• Sheathless system
• Glidesheath slender
• 6F IABP
We had our ups and downs.
Puncture to balloon time was also significantly shorter in IL group compared with conventional group.
We realized that 3 Fr sheath outer diameter is nearly equivalent to that of 5Fr guiding catheter .
Using 5Fr sheathless guiding system will allow access to almost all the techniques and devices, and at the same time, will meet the need to be minimally invasive
We have used 5 Fr Ikari guiding catheter and combined it with 3Fr central dilator, and made a sheathless guiding catheter system.
The target lesion is mid LAD and mid RCA
We implanted Cypher to mid LAD
We even tried Kissing balloon technique, and it was successfully done.
And this if final angiography of LAD
Then we moved on to PCI to RCA.
We used the same Ikari catheter and reversed it.
As you can see, it was smoothly engaged to RCA.
Implanted Cypher
Thank you very much.
I’m deeply grateful to you all.