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.