Brachial IABP to support complex transradial PCI, Y Ikari

1. Brachial IABP to Support
Complex Transradial PCI
Yuji Ikari, MD.
Department of Cardiology
Tokai University School of Medicine
Budapest 2016

2. Disclosures
• I have no conflict of interest to declare

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

9. 0.025-inch Guidewire
: Central Dilator
5Fr. IKARI Guiding Catheter

10. Puncture with a 22-gauge, and introduce 0.018-inch guidewire
0.018–inch Guidewire

11. 0.018–inch Guidewire
Remove the 22G outer needle.

12. Exchange from 0.018-inch guide wire to 0.025-inch guidewire after
inserting the short dilator.
0.025–inch Guidewire

13. Remove the dilator.
0.025–inch Guidewire

14. Insert 5Fr. IL guiding catheter and manipulate it with the central dilator.

15. ↑18G TERUMO NEEDLE (1.20mm)
↑３F Ikari left (1.17mm)
Virtual 1F=19G
Ijichi et al. Catheter Cardiovasc Interv 2013;82:E676

16. CAG LCA
19G CAG
Ijichi et al. Catheter Cardiovasc Interv 2013;82:E676

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.

25. 6Fr IABP
via Lt. Brachial
Trans-Brachial IABP insertion Method

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

33. 6Fr-IABP 8Fr-IABP P-value
(n=20) (n=22)
Male 15 (75%) 17 (77.3%) 0.867
Age (years) 72.3±8.8 71.2±7.9 0.945
Height (cm) 160.4±8.6 160.0±7.8 0.829
Weight (kg) 57.5±11.9 57.2±10.0 0.609
Smoking 9 (45.0%) 5 (22.7%) 0.192
Diabetes Mellitus 12 (60%) 6 (27.3%) 0.060
Dyslipidemia 13 (65%) 11 (50%) 0.366
Hypertension 18 (90%) 19 (86.4%) 1.000
Old Myocardial Infarction 6 (30%) 13 (59.1%) 0.072
prior PCI 10 (50%) 11 (50%) 1.000
prior CABG 0 0 N/A
Aspirin and Thienopyridine
Preloading
20 (100%) 22 (100%) N/A
Patient Characteristics

34. 6Fr-IABP 8Fr-IABP P-value
(n=20) (n=22)
LM-related 19 (95.0%) 20 (90.1%) 1.000
3-Vessels Disease 2 (10.0%) 2 (9.1%) 1.000
Ejection Fraction (%) 58.4±16.2 60.9±17.9 0.671
Target Lesion Characteristics

35. Procedural Characteristics
6Fr-IABP 8Fr-IABP P-value
(n=20) (n=22)
GC Size (Fr) 6.1±0.5 6.6±0.8 0.011
IABP Volume (ml) 30.0±0.0 35.4±5.7 <0.001
Numbers of Stent 2.1±1.2 1.8±1.0 0.927
Procedural Time (min) 141.9±56.6 108.1±60.7 0.092
Fluoroscopy Time (min) 42.9±24.7 28.7±19.9 0.055
IABP Actuation Time (min) 127.1±59.2 87.9±52.3 0.044
Contrast Volume (ml) 246.9±106.2 223.8±95.2 0.479
Total Heparin (units) 8277.8±1564.5 7617.6±1798.7 0.254

36. 6Fr-IABP 8Fr-IABP P-value
(n=20) (n=22)
Procedure Success 20 (100%) 22 (100%) N/A
IABP access site complications: 0 3 (13.6%) 0.091
Re-bleeding 0 3 (13.6%)
0.091Hematoma (>5cm) 0 3 (13.6%)
Blood Transfusion 0 3 (13.6%)
In-hospital MACCE 0 0 N/A
In-hospital Death 0 0 N/A
ΔHemoglobin (g/dl) -0.9±1.2 -1.5±0.9 0.064
ΔHematocrit (%) -2.9±3.9 -4.3±3.0 0.192
ΔPletelet (×104/µl) -2.0±3.0 -1.7±2.1 0.706
Bed Rest Time after PCI (min) 75.8±139.8 360.0±104.7 <0.001
In-hospital Stay after PCI (days) 1.0 (1.0-2.8) 2.0 (1.0-5.0) 0.899
Defer the Discharge for Bleeding
Complications
0 3 (13.6%) 0.091
Re-hospitalization for Bleeding
Complications
0 1 (4.5%) 0.347
Results

37. 6Fr TB-IABP 6Fr TF-IABP 8Fr TF-IABP
P-value
(n=15) (n=5) (n=22)
IABP access site complications 0 0 3 (13.6%) 0.243
In-hospital MACCE 0 0 0 N/A
In-hospital Death 0 0 0 N/A
ΔHemoglobin (g/dl) -0.8±0.9 -1.2±1.9 -1.5±0.9 0.137
ΔHematocrit (%) -2.5±3.0 -4.7±5.3 -4.3±3.0 <0.001
ΔPletelet (×104/µl) -1.3±2.2 -4.3±3.9 -1.7±2.1 <0.001
Bed Rest Time after PCI (min) 0.0±0.0 288.0±107.3 360.0±104.7 <0.001
In-hospital Stay after PCI (days)
1.0
(1.0-2.0)
5.0
(3.0-8.0)
2.0
(1.0-5.0)
0.007
Defer the Discharge for Bleeding
Complications
0 0 3 (13.6%) 0.243
Re-hospitalization for Bleeding
Complications
0 0 1 (4.5%) 0.646
Results

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.

41. Limitations (Approach)
 Rt.Brachial and Lt.Radial artery are not
available.
This IABP catheter is too short to insert via
radial approaches.

42. Limitations (Patients)
Not applicable to patients with subclavian
arterial stenosis.

43. Limitations (Patients)
Not applicable to patients with so-called
type III arch.
⇒Checking the arch anatomy is important
for safe TB-IABP.

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.

45. Slender Club Japan
http://www.cardiologist.jp/ptca5fr/scj.htm