ikari y - aimradial 2014 - radial and iabp
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Radial approach and intra-aortic balloon pumpTRANSCRIPT
Radial Approach and Slender
Intra-Aortic Balloon Puming
Yuji Ikari, MD.Department of CardiologyTokai University School of Medicine
Chicago, IL Oct 2014
Doyle BJ et al. JACC Intervention 2008;1:202-209.
BackgroundMajor Femoral Bleeding Complications
Impact on Survival
Standardized Mortality Rate in Patients Undergoing PCIBased Upon the Guide Catheter Size
Larger guiding catheter had higher mortality.
Grossman PM, et al. JACC Cardiovasc Interv. 2009 Jul;2(7):636-44.
< <
“Bigger is NOT Better”Grossman PM, et al. JACC Cardiovascular Interv. 2009 Jul;2(7):636-44.
Percutaneous Coronary Intervention Complications and Guide Catheter Size
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
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
6Fr is OK from Trans-brachial IABP
But transradial is impossible
due to the short catheter length
777mm
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.
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.
6Fr IABPvia Lt. Brachial
Trans-Brachial IABP insertion Method
Pressure wave pattern ofthe guiding catheter
6Fr IABPvia Lt. Brachial
Trans-Brachial IABP insertion Method
IABP Remove & Hemostasis
Removing with a brachial compression device (Tometa-kun™).
Fujii T, Masuda N, et al. J Invasive Cardiol. 2012 Dec;24(12):641-4.
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
42 elective PCI cases
with a prophylactic
IABP assistance
6Fr TB-IABP (n=15)
6Fr TF-IABP(n=5)
8Fr TF-IABP(n=22)
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
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
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
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
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
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
6Fr TB-IABP 6Fr TF-IABP 8Fr TF-IABPP-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
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
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
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.
Limitations (Approach)
Rt.Brachial and Lt.Radial artery are not available.
This IABP catheter is too short to insert via radial approaches.
Limitations (Patients)
Not applicable to patients with subclavian arterial stenosis.
Limitations (Patients)
Not applicable to patients with so-called type III arch.
⇒Checking the arch anatomy is important for safe TB-IABP.
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.
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.