This document discusses the use of a slender 6Fr intra-aortic balloon pump (IABP) system compared to the standard 8Fr system. A study of 42 patients undergoing elective percutaneous coronary intervention with prophylactic IABP support found no complications with the 6Fr system, while the 8Fr system had re-bleeding and hematoma in some patients. The 6Fr system also allowed for shorter bed rest time. Trans-brachial insertion of the 6Fr IABP had even shorter bed rest and hospital stay times than transfemoral insertion. However, the 6Fr system has limitations such as a small balloon volume and inability to monitor pressure or use radial approaches.

1. Radial Approach and Slender
Intra-Aortic Balloon Puming
Yuji Ikari, MD.
Department of Cardiology
Tokai University School of Medicine
Chicago, IL Oct 2014

2. Background
Major Femoral Bleeding Complications
Impact on Survival
Doyle BJ et al. JACC Intervention 2008;1:202-209.

3. Standardized Mortality Rate in Patients Undergoing PCI
Based Upon the Guide Catheter Size
Larger guiding catheter had higher mortality.
Grossman PM, et al. JACC Cardiovasc Interv. 2009 Jul;2(7):636-44.

4. Percutaneous Coronary Intervention
Complications and Guide Catheter Size
< <
“Bigger is NOT Better”
Grossman PM, et al. JACC Cardiovascular Interv. 2009 Jul;2(7):636-44.

5. Transradial Approach with
Slender Cath is Superior!!!!
• However, cardiac assist device such as
IABP is necessary for complex PCI.
GLOBAL CALIBRATION
7.5 Fr or 8 Fr
LM occlusion

6. 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 777mm
0.017inch

7. 6Fr is OK from Trans-brachial IABP
But transradial is impossible
due to the short catheter length
777mm

8. Indication of Trans-brachial IABP
 IABP is necessary but no femoral approach site.
 Brachial approach may be beneficial compared
with femoral approach
・There’s no need to keep the supine position.

9. 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.

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

11. Trans-Brachial IABP insertion Method
Pressure wave pattern of
the guiding catheter
6Fr IABP
via Lt. Brachial

12. IABP Remove & Hemostasis
Removing with a brachial compression device (Tometa-kun™).

13. Fujii T, Masuda N, et al. J Invasive Cardiol. 2012 Dec;24(12):641-4.

14. Aim
To show clinical outcomes 6Fr-IABP
support in comparison with 8-Fr
IABP.
Subjects
Consecutive 42 patients who
underwent elective PCI with a
prophylactic IABP assistance from
January 2006 to December 2009 at
Tokai University Hospital

15. 42 elective PCI cases
with a prophylactic
IABP assistance
6Fr TB-IABP (n=15)
6Fr TF-IABP(n=5)
8Fr TF-IABP(n=22)

16. 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

17. Devices
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.

18. Patient Characteristics
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
20 (100%) 22 (100%) N/A
Preloading

19. Target Lesion Characteristics
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

20. 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

21. Results
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%)
Hematoma (>5cm) 0 3 (13.6%) 0.091
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
0 3 (13.6%) 0.091
Complications
Re-hospitalization for Bleeding
Complications
0 1 (4.5%) 0.347

22. Results
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

23. Summary
 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.

24. 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

25. 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.

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

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

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

29. 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.

30. Take Home Message
Along with an increase in complex
coronary interventions that might
require hemodynamic support, not
only conventional trans-femoral 6-Fr
IABP assistance but also trans-brachial
6-Fr IABP insertion are sure
to be useful options for
interventional cardiologists.