3. Background
• Slender system is good for patients but
bad for operators.
• Which is important?
• We believe that slender transradial PCI is
the best.
4. Slender Club Japan has developed
slender technique and device
• 0.010 inch wire and balloon system
– KBT in 5 Fr & KGT in 6 Fr
• Virtual 3 Fr PCI or Virtual 1 Fr diagnostic
angio
• Glidesheath slender
• And others
Also, SCJ has reported limitations
5. Tip Entry Profile: 0.014-inch 0.012-inch
(0.36 mm 0.31 mm)
OLD NEW
0.0120.014
0.010
6. 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
7. 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
8. 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
Ten Balloon is good. However, 0.010 guidewire
was too weak to deliver a regular stent
17. 19G CAG
Terumo gave up sales because manufacturing
cost was higher than sales cost
18. Thinner sheath wall thickness to
make outer diameter smaller
*Intended to use only radial approach
Design Concept
19. 3 size variation to improve daily TRI practice
5Fr
Less invasiveness
6Fr
Daily Practice
7Fr
Complex PCI
Size variation
20. Transradial Approach with
Slender Catheter has
Advantages!!!!
• However, cardiac assist device such as
IABP is necessary for complex PCI.
GLOBAL CALIBRATION
7.5 Fr or 8 Fr
LM occlusion
21. 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
22. 6Fr is OK from Trans-brachial IABP
But transradial is impossible
due to the short catheter length
777mm
23. Indication of Trans-brachial IABP
IABP is necessary but no femoral approach site.
Brachial approach is beneficial compared with
femoral approach due to no need to keep the
supine position.
We know the limitation of
median nerve injury
24. Quantitative Assess of Brachial
Artery Inner Lumen Diameter
We previously reported that the mean lumen diameter of the
brachial artery was 4.53 ± 0.62 mm.
6-Fr can be applied to the brachial artery in terms of the arterial
size.
Fujii T, Masuda N, et al. J Invasive Cardiol. 2010 Aug;22(8):372-6.
26. Pressure wave pattern of
the guiding catheter
6Fr IABP
via Lt. Brachial
Trans-Brachial IABP insertion Method
27. IABP Remove & Hemostasis
Removing with a brachial compression device (Tometa-kun™).
28. Fujii T, Masuda N, et al. J Invasive Cardiol. 2012 Dec;24(12):641-4.
29. Aim
To show clinical outcomes 6Fr-IABP
support in comparison with 8-Fr
IABP.
Consecutive 42 patients who
underwent elective PCI with a
prophylactic IABP assistance from
January 2006 to December 2009 at
Tokai University Hospital
Subjects
30. 42 elective PCI cases
with a prophylactic
IABP assistance
6Fr TB-IABP (n=15)
6Fr TF-IABP(n=5)
8Fr TF-IABP(n=22)
31. Endpoints
Primary Endpoint:
IABP access site complications:
Re-bleeding
Hematoma (>5cm)
Blood Transfusion
Secondary Endpoints:
In-hospital MACCE (Death, MI, Stroke)
ΔHemoglobin, ΔHematocrit, ΔPletelet
Bed Rest Time after PCI
In-hospital Stay after PCI
Defer the Discharge/Re-hospitalization for
Bleeding Complications
32. Two different IABP systems were
Slenderized: 6-Fr IABP system
(Takumi; Zeon Medical)
Conventional: 8-Fr IABP system
(TRUE8-Super Track; Datascope)
Selection of either system was at operator
discretion.
Devices
38. We studied clinical benefits and adverse
events of the 6-Fr IABP system by
comparison with the conventional 8-Fr IABP
system.
No adverse events were observed in the 6-Fr
IABP system.
The 6-Fr IABP system was superior to 8-Fr
IABP in terms of shorter bed rest time.
TB-IABP was superior to TF-IABP in terms of
shorter bed rest time and shorter hospital
stay.
Summary
39. Study Limitation
Not randomize study
Retrospective study and small
sample
This sample size might explain why we did not see
statistically significant differences in IABP access-site
complications.
Only prophylactic-IABP cases
40. Limitations (Device)
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.
44. Conclusion
The 6-Fr IABP system will be feasible in
clinical use and advantageous in terms
of lower access-site complications.
TB-IABP application will be also possible
using this system to achieve shorter
bed rest time and shorter hospital stay.
We have used 5 Fr Ikari guiding catheter and combined it with 3Fr central dilator, and made a sheathless guiding catheter system.
Puncture radial artery with a 22 gauge, and introduce 0.018 inch guidewire
Remove the outer needle
Insert the short dilator, and exchange to 0.025 inch guidewire
Remove the dilator
And insert 5Fr IL guiding catheter and manipulate it with the inserted central dilator.
Thank you very much.
I’m deeply grateful to you all.
As you know, major bleeding after PCI negatively impact on survival.
And, the mortality of large guide catheter PCI patients was higher than small guide patients.
These data suggest that selection of smaller guide catheters may result in improved clinical outcome in patients undergoing contemporary PCI.
Here is large multi-centers registry data.
This study shows large size catheter are associated with many bad outcomes such as more vascular complications, contrast agent use, more CIN and a greater need for blood transfusion.