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Brachial IABP to Support
Complex Transradial PCI and
Slender Club Japan
Yuji Ikari, MD
Department of Cardiology
Tokai University School of Medicine,
Japan
Stuttgart 2017
Disclosure conflict of interest
No conflict of interest to declare
Slender Club Japan (SCJ)
• SCJ is organized by the Three
Musketeers.
• SCJ has developed new slender
techniques
– Emperor’s new clothes
– Chameleon
• SCJ has advised Japanese
companies to develop new slender
devices.
Slender Devices
• Ikari guiding catheter
• 0.010 inch system
• Sheathless system
• Glidesheath slender
• 6F IABP
• And others
Now, many types of Ikari L are available.
Terumo
Heartrail2
Asahi Intech
Hyperion
Goodman
Profit
Medtronics
Launcher
Ikari L concept
Judkins L easily looses engagement in TRI
Ikari L has stable engagement
Hypothesis; physics of backup force
• Fcosq =k(fcosq’ + l)
• fcosq ’ + l
Fmax = k ―――――
cosq
Maximum backup force is
acheved if
q=90 degree; q’= 0
degree; or l is large.
q’ q
l
Ikari et al. J Invasive Cardiol 2005 ;17:636-41
Judkins L can generate greater
backup force in TFI than in TRI.
θr
A
θf
B
0
10
20
30
40
50
60
70
TRI TFI
resistance(gramforce)
P<0.05
Ikari et al. J Invasive Cardiol 2005 ;17:636-41
Deep engagement increases
backup force in Judkins L
θ4 θ4deep
0
10
20
30
40
50
60
JL4.0 JL4.0 Deep
resistance(gramforce)
P<0.05
Ikari et al. J Invasive Cardiol 2005 ;17:636-41
θi
θfθr
Ikari L Power Position is not Deep!
11
A B
C D
Ikari LPower Position is not Deep!
Safe Procedure
TRI for Right Coronary Artery
Amplatz L Ikari L Judkins R Ikari L
With 035 inch GW
Angiography by Ikari-L 3.5
6Fr
N = 621
Ad hoc PCI
N =380 (61.2%)
Primary endpoint
Device efficacy
Device safety
Secondary
endpoint
Procedural success
Engagement rate
Procedure time
Fluoroscopy time
Contrast volume
EuroInterv. 2007; 3: 475-481.
Engagement rate
RCA 609(98.1%)
LCA 617(99.4%)
STEMI: ST elevation in II, III, aVF
Primary PCI was tried in another hospital
They tried TRI using a 6F Amplatz Left 1.
A guidewire passed the lesion but a balloon
could not. They failed PCI despite 3 hours
procedure.
Final
The patient transferred to our hospital.
A young doctor successfully performed POBA
using a 7F Ikari L and anchor balloon technique.
TIMI 3 flow was achieved.
I performed PCI using a 6F Ikari L without any
techniques such as anchor balloon.
Power position of Ikari L
Comparison in TRI
JR IR AL IL
0
20
40
60
80
100
120
140
160
JR4 IR1.5 AL1 IL3.5
maxresistance(gforce)
New Concept of Ikari L for STEMI
• TRI for STEMI Improves
Mortality
• Shorter D2B time is
necessary
• If Ikari L is used you can
shorten reperfusion time
Primary PCI for STEMI
1) Radial artery puncture
2) Insertion of diagnostic catheter (L)
3) Engagement of diagnostic catheter (L) for LCA
4) Angiography of LCA
5) Removal of the catheter (L)
6) Insertion of diagnostic catheter (R)
7) Engagmennt of diagnostic catheter (R) for RCA
8) Angiography of RCA
9) Removal of the catheter (R)
10) Insertion of a guiding catheter
11) Engagement of the guiding catheter
12) Guidewire passage
13) First device activation (balloon or thrombus aspiration)=Reperfusion
Catheter insertion 3 → 1
Catheter removal 2 → 0
Engagement 3 → 2
Puncture to Balloon time
10 (7-12)min 17 (13-23) min
p=0.001
IL
group
Conventional
group
min
Cardiovasc Interv and Ther
DOI 10.1007/s12928-016-0395-z
Tip Entry Profile: 0.014-inch 0.012-inch
(0.36 mm 0.31 mm)
OLD NEW
0.0120.014
0.010
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
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
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
A 010 Balloon is good.
However, there is a limitation in 010 guidewires.
3 Fr Sheath O.D. Sheathless 5 Fr G.C
1.70 mm 1.71 mm
3 5
0.059 inch 0.059 inch
≒
A 5F Guiding catheter is used without a sheath,
It is equal to 3F sheath size.
0.025-inch Guidewire
: Central Dilator
5Fr. IKARI Guiding Catheter
Medikit
iWorks virtual 3F
Terumo Heartrail2
IFL
Target lesions: Mid LAD & Mid RCA
STENT
Cypher 3.0 x 23mm: 16atm
Two stents were implanted using 010 GWs
Kissing Balloon Technique
Final Angiography of LAD
IL4.0 : 5Fr
Guiding Catheter
STENT
Cypher 3.0 x 28mm: 16 atm
↑18G TERUMO NEEDLE (1.20mm)
↑3F Ikari left (1.17mm)
Virtual 1F
Sheathless 3F diagnositic angio
Ijichi et al. Catheter Cardiovasc Interv 2013;82:E676
CAG LCA
Virtual 1Fr
Virtual 1 Fr
CAG RCA
Virtual 1F=19G needle size
Terumo gave up sales because manufacturing
cost was higher than sales cost
Thinner sheath wall thickness to
make outer diameter smaller
*Intended to use only radial approach
Design Concept
3 size variation to improve daily TRI practice
5Fr
Less invasiveness
6Fr
Daily Practice
7Fr
Complex PCI
Size variation
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
6Fr IABP
via Lt. Brachial
Trans-Brachial IABP insertion Method
Pressure wave pattern of
the guiding catheter
6Fr IABP
via 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.
42 elective PCI cases
with a prophylactic
IABP assistance
6Fr TB-IABP (n=15)
6Fr TF-IABP(n=5)
8Fr TF-IABP(n=22)
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 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
Limitations (Device)
 Guidewire 0.014 compatible
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 (Patients)
Not applicable to patients with so-called
type III arch.
⇒Checking the arch anatomy is important
for safe TB-IABP.
Summary : 6F IABP
The 6-Fr IABP system was feasible in
clinical use with lower bleeding
complications.
However, TB-IABP has several critical
limitations such as no blood pressure
monitoring, potential risk for subclavian
artery or more time necessary for the
procedure due to less support of 0.014
inch GW.
Slender Club Japan has advised Japanese
companies on development of slender
devices
• Ikari guiding catheter
• 0.010 inch system
• Sheathless system
• Glidesheath slender
• 6F IABP
We had our ups and downs.
Slender Club Japan
http://www.cardiologist.jp/ptca5fr/scj.htm

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Brachial IABP to Support Complex Transradial PCI

  • 1. Brachial IABP to Support Complex Transradial PCI and Slender Club Japan Yuji Ikari, MD Department of Cardiology Tokai University School of Medicine, Japan Stuttgart 2017
  • 2. Disclosure conflict of interest No conflict of interest to declare
  • 3. Slender Club Japan (SCJ) • SCJ is organized by the Three Musketeers. • SCJ has developed new slender techniques – Emperor’s new clothes – Chameleon • SCJ has advised Japanese companies to develop new slender devices.
  • 4. Slender Devices • Ikari guiding catheter • 0.010 inch system • Sheathless system • Glidesheath slender • 6F IABP • And others
  • 5. Now, many types of Ikari L are available. Terumo Heartrail2 Asahi Intech Hyperion Goodman Profit Medtronics Launcher
  • 6. Ikari L concept Judkins L easily looses engagement in TRI Ikari L has stable engagement
  • 7. Hypothesis; physics of backup force • Fcosq =k(fcosq’ + l) • fcosq ’ + l Fmax = k ――――― cosq Maximum backup force is acheved if q=90 degree; q’= 0 degree; or l is large. q’ q l Ikari et al. J Invasive Cardiol 2005 ;17:636-41
  • 8. Judkins L can generate greater backup force in TFI than in TRI. θr A θf B 0 10 20 30 40 50 60 70 TRI TFI resistance(gramforce) P<0.05 Ikari et al. J Invasive Cardiol 2005 ;17:636-41
  • 9. Deep engagement increases backup force in Judkins L θ4 θ4deep 0 10 20 30 40 50 60 JL4.0 JL4.0 Deep resistance(gramforce) P<0.05 Ikari et al. J Invasive Cardiol 2005 ;17:636-41
  • 11. Ikari L Power Position is not Deep! 11 A B C D
  • 12. Ikari LPower Position is not Deep! Safe Procedure
  • 13. TRI for Right Coronary Artery Amplatz L Ikari L Judkins R Ikari L With 035 inch GW
  • 14. Angiography by Ikari-L 3.5 6Fr N = 621 Ad hoc PCI N =380 (61.2%) Primary endpoint Device efficacy Device safety Secondary endpoint Procedural success Engagement rate Procedure time Fluoroscopy time Contrast volume EuroInterv. 2007; 3: 475-481. Engagement rate RCA 609(98.1%) LCA 617(99.4%)
  • 15. STEMI: ST elevation in II, III, aVF Primary PCI was tried in another hospital
  • 16. They tried TRI using a 6F Amplatz Left 1. A guidewire passed the lesion but a balloon could not. They failed PCI despite 3 hours procedure. Final
  • 17. The patient transferred to our hospital. A young doctor successfully performed POBA using a 7F Ikari L and anchor balloon technique. TIMI 3 flow was achieved.
  • 18. I performed PCI using a 6F Ikari L without any techniques such as anchor balloon. Power position of Ikari L
  • 19. Comparison in TRI JR IR AL IL 0 20 40 60 80 100 120 140 160 JR4 IR1.5 AL1 IL3.5 maxresistance(gforce)
  • 20. New Concept of Ikari L for STEMI • TRI for STEMI Improves Mortality • Shorter D2B time is necessary • If Ikari L is used you can shorten reperfusion time
  • 21. Primary PCI for STEMI 1) Radial artery puncture 2) Insertion of diagnostic catheter (L) 3) Engagement of diagnostic catheter (L) for LCA 4) Angiography of LCA 5) Removal of the catheter (L) 6) Insertion of diagnostic catheter (R) 7) Engagmennt of diagnostic catheter (R) for RCA 8) Angiography of RCA 9) Removal of the catheter (R) 10) Insertion of a guiding catheter 11) Engagement of the guiding catheter 12) Guidewire passage 13) First device activation (balloon or thrombus aspiration)=Reperfusion Catheter insertion 3 → 1 Catheter removal 2 → 0 Engagement 3 → 2
  • 22. Puncture to Balloon time 10 (7-12)min 17 (13-23) min p=0.001 IL group Conventional group min Cardiovasc Interv and Ther DOI 10.1007/s12928-016-0395-z
  • 23. Tip Entry Profile: 0.014-inch 0.012-inch (0.36 mm 0.31 mm) OLD NEW 0.0120.014 0.010
  • 24. 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
  • 25. 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
  • 26. 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 A 010 Balloon is good. However, there is a limitation in 010 guidewires.
  • 27. 3 Fr Sheath O.D. Sheathless 5 Fr G.C 1.70 mm 1.71 mm 3 5 0.059 inch 0.059 inch ≒ A 5F Guiding catheter is used without a sheath, It is equal to 3F sheath size.
  • 28. 0.025-inch Guidewire : Central Dilator 5Fr. IKARI Guiding Catheter
  • 30. Target lesions: Mid LAD & Mid RCA
  • 31. STENT Cypher 3.0 x 23mm: 16atm Two stents were implanted using 010 GWs
  • 35. STENT Cypher 3.0 x 28mm: 16 atm
  • 36. ↑18G TERUMO NEEDLE (1.20mm) ↑3F Ikari left (1.17mm) Virtual 1F Sheathless 3F diagnositic angio Ijichi et al. Catheter Cardiovasc Interv 2013;82:E676
  • 39. Virtual 1F=19G needle size Terumo gave up sales because manufacturing cost was higher than sales cost
  • 40. Thinner sheath wall thickness to make outer diameter smaller *Intended to use only radial approach Design Concept
  • 41. 3 size variation to improve daily TRI practice 5Fr Less invasiveness 6Fr Daily Practice 7Fr Complex PCI Size variation
  • 42. 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
  • 43. 6Fr IABP via Lt. Brachial Trans-Brachial IABP insertion Method
  • 44. Pressure wave pattern of the guiding catheter 6Fr IABP via Lt. Brachial Trans-Brachial IABP insertion Method
  • 45. IABP Remove & Hemostasis Removing with a brachial compression device (Tometa-kun™).
  • 46. Fujii T, Masuda N, et al. J Invasive Cardiol. 2012 Dec;24(12):641-4.
  • 47. 42 elective PCI cases with a prophylactic IABP assistance 6Fr TB-IABP (n=15) 6Fr TF-IABP(n=5) 8Fr TF-IABP(n=22)
  • 48. 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
  • 49. 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
  • 50. Limitations (Device)  Guidewire 0.014 compatible 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.
  • 51. Limitations (Patients) Not applicable to patients with so-called type III arch. ⇒Checking the arch anatomy is important for safe TB-IABP.
  • 52. Summary : 6F IABP The 6-Fr IABP system was feasible in clinical use with lower bleeding complications. However, TB-IABP has several critical limitations such as no blood pressure monitoring, potential risk for subclavian artery or more time necessary for the procedure due to less support of 0.014 inch GW.
  • 53. Slender Club Japan has advised Japanese companies on development of slender devices • Ikari guiding catheter • 0.010 inch system • Sheathless system • Glidesheath slender • 6F IABP We had our ups and downs.

Editor's Notes

  1. Puncture to balloon time was also significantly shorter in IL group compared with conventional group.
  2. We realized that 3 Fr sheath outer diameter is nearly equivalent to that of 5Fr guiding catheter . Using 5Fr sheathless guiding system will allow access to almost all the techniques and devices, and at the same time, will meet the need to be minimally invasive
  3. We have used 5 Fr Ikari guiding catheter and combined it with 3Fr central dilator, and made a sheathless guiding catheter system.
  4. The target lesion is mid LAD and mid RCA
  5. We implanted Cypher to mid LAD
  6. We even tried Kissing balloon technique, and it was successfully done.
  7. And this if final angiography of LAD
  8. Then we moved on to PCI to RCA. We used the same Ikari catheter and reversed it. As you can see, it was smoothly engaged to RCA.
  9. Implanted Cypher
  10. Thank you very much. I’m deeply grateful to you all.