innovation in transradial access - medisquare › wp-content › uploads › 2016 › ...transradial...
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Innovation in Transradial access
Aminian Adel, MD
CHU Charleroi
Belgium
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Potential conflicts of interest
Speaker's name: Adel Aminian
I do not have any potential conflict of interest
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Limitations of TR access?
« In case of complex PCI, I could not use large bore guide
catheters »
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Sheath size and radial artery suitability
Saito et al CCI 2009
DOWNSIZING: THE FUTURE OF TRI !
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How to overcome sheath to artery mismatch?
« SHEATH-BASED » APPROACH: THE TERUMO SLENDER SHEATH
OD 2.63 mm OD 2.45 mm
EQUIVALENT DIAMETER ID 2.22 mm 5Fr Sheath ID 2.22 mm
6Fr Sheath
Source: Terumo Corp., Japan
EQUIVALENT LUMEN
EQUIVALENT DIAMETER
DOWN SIZING
ULTRA-THIN WALL RESULTING IN A REDUCTION IN OUTER
DIAMETER WITH EQUIVALENT INNER DIAMETER
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CCI 2014;84:436-42
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GLIDESHEATH SLENDER From “5 to 7” Fr Compatible
THE SMALLEST 5 Fr / 6 Fr / 7 Fr SHEATHS CURRENTLY ON THE MARKET
2,06 2,09 2,09
2,13
2,29
2,41
2,48 2,52
2,46
2,62
2,73 2,74
2,88
2,79
2,97 3,02
3,08
1,7
1,9
2,1
2,3
2,5
2,7
2,9
3,1
3,3
Cook FlexorCheck Flo 4F
CordisRadialSource
4F
MeritMedicalPrelude
Radial 4F
TerumoGlidesheathSlender 5F
TerumoRadifocus
Introducer II5F
Cook FlexorCheck Flo 5F
CordisRadialSource
5F
MeritMedicalPrelude
Radial 5F
TerumoGlidesheathSlender 6F
TerumoRadifocus
Introducer II6F
Cook FlexorCheck Flo 6F
CordisRadialSource
6F
MeritMedicalPrelude
Radial 6F
TerumoGlidesheathSlender 7F
TerumoRadifocus
Introducer II7F
CordisRadialSource
7F
Cook FlexorCheck Flo 7F
O.D. in mm
Above measurements taken from internal evaluation of competitive devices.
Engineering Data on File. 4Fr 5Fr 6Fr 7Fr
- 0.29 mm
- 0.42 mm
- 0.39 mm
Ensuring access devices have the smallest possible outer diameter is crucial during TR procedures!
GSS7
GSS6
GSS5
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• Multicenter registry
– CHU CHARLEROI (Dr AMINIAN)
– CHUV (Dr IGLESIAS)
– OLV AALST (Dr VAN MIEGHEM)
– Guest Investigator : Dr SHIGERU SAITO
• Current enrollment= 60 patients
• Inclusion criterias:
– Patient eligible for complex TR coronary intervention requiring the use of a 7Fr GC according to operator opinion and expertise
– Elective and emergent PCI
• Primary end-point: procedural success
• Secondary end-point: vascular complication, spasm and RAO
First clinical experience with the 7Fr Glidesheath Slender for complex PCI:
A multi-center registry with prospective radial ultrasound follow-up
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3 DK CRUSH
4 TAP 3 DK CRUSH 2 Culotte
4 BIRADIAL7Fr
Maximal burr size: 1.5 (n=5), 1.75 (n=4), 2 (n=1)
3 Triple KB
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Individual-based approach for sheath selection
Procedural success RA patency
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Slender sheaths: Tailored approach for TR access!
Diagnostic angiography Small RA (women) « Elective simple PCI » Lowest rate of radial injury,
spasm and RAO Estimated rate RAO <1%
GSS5 OD 2.16mm
GSS6 OD 2.46mm
GSS7 OD 2.79mm
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All comer sheath (diagnostic and PCI)
Complex PCI (bifurcation, rotablation)
>90% of routine PCI procedures
Low rate of radial injury, spasm and RAO
Estimated rate of RAO 1-3%
Slender sheaths: Tailored approach for TR access!
GSS5 OD 2.16mm
GSS6 OD 2.46mm
GSS7 OD 2.79mm
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Complex PCI (Left main, complex bifurcation, rotablation, CTO,…)
10-15% of PCI procedures Acceptable rate of radial
injury, spasm and RAO Estimated rate of RAO 5%
Slender sheaths: Tailored approach for TR access!
GSS5 OD 2.16mm
GSS6 OD 2.46mm
GSS7 OD 2.79mm
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Conclusions
Transradial access has demonstrated a broad spectrum of benefits vs transfemoral access, from clinical endpoints to patient reported outcomes
Uptake of the transradial approach is increasing, and experience with the technique is continually growing, even in complex cases
The innovative thin-wall technology used by Glidesheath Slender® makes transradial access an option even in the most challenging scenarios
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THANK YOU!
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BACK UP SLIDES
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RAP and BEAT:Procedure Results (2⁰ Endpoint)
6Fr GSS 5Fr Conventional p
N 925 917
Procedure Time (min) 28.8 ± 23.8 27.6 ± 20.6 0.268
Radiation (µGy) 796 ± 884 764 ±605 0.366
Contrast (ml) 86.0 ±49.6 85.9 ± 54.6 0.995
Pain (%) None Slight Much Extreme
610 (66.6) 266 (29.0)
36 (3.9) 4 (0.4)
645 (70.5) 223 (24.4)
44 (3.9) 3 (0.3)
0.117
Sheath Failure (%) 11 (1.2) 5 (0.5) 0.208
Procedure Success (%) 907 (99.0) 907 (99.1) 1.000
Spasm (%) 38 (4.1) 50 (5.5) 0.192
Patent Hemostasis (%) 445 (48.6) 469 (51.3) 0.262
Vascular Comp (%) 5 (0.5) 5 (0.5) 1.000
Sheath Failure: Any malfunction which lead to vascular complication and/or procedure failure. Procedure Success: Completion of the planned procedure through the initially selected radial access rout.
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RAP and BEAT: Procedure Result (1⁰ Endpoint)
6Fr GSS 5Fr Conventional p
N 925 917
RAO (%) 31 (3.4) 16 (1.7) 0.038
RAO: The absence of a patent radial artery assessed by 2D Doppler ultrasound examination of the radial artery at discharge or the next day (the earlier of the two)
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An access solution for many different types
of procedures
21
IVUS, intravascular ultrasound; OCT, optical coherence tomography; OFDI, optical frequency domain
imaging; TAP, T-stenting and small protrusion . .
Adapted from: http://www.slideshare.net/theradialist/louvard-y-aimradial-2014-technical-bifurcation-and-
radial-approach (accessed March 2016).
For complex PCI
and larger devices:
rotablation,
bifurcation, left
main, CTO, etc
Size Devices1 Techniques1
5Fr
• Balloons ≤5 mm
• Stents ≤4.5 mm
• Cutting Balloon < 2.5 mm
• Rotablation burrs ~1.25 mm
• Balloon angioplasty
• Standard single stenting
• Not kissing balloons
6Fr
• All coronary balloons
• All coronary stents
• Cutting Balloon
• OFDI/OCT/IVUS
• Rotablation burrs ≤1.75 mm
• Thromboaspiration
• Embolic protection devices
• Balloon angioplasty
• Kissing balloon
• Standard single stenting
• T- and modified T-
stenting, TAP, Culotte
• Not kissing stents
7Fr
• All coronary balloons
• All coronary stents
• OFDI/OCT/IVUS
• Rotablation burrs 2.0 mm
• Thromboaspiration
• Embolic protection devices
• Single, double stenting
• Kissing balloon
• Kissing stent • Crush, mini-crush, step
crush, V-stenting
Less invasive for
patients with small
radial artery
diameter
Standard size for
everyday clinical
practice
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When do we need 7Fr guide catheters?
• Better backup support
• Better quality of contrast injection
• Specific anatomical settings and techniques
– Rotablation (large burr > 1.5 mm)
– Large 7Fr thromboaspiration catheter (STEMI)
– Complex bifurcation stenting (2 stents technique)
– Left main stenting
– CTO
– Complex anatomy (tortuous vessel- calcification)