Innovation in Transradial access

Aminian Adel, MD

CHU Charleroi

Belgium

Potential conflicts of interest

Speaker's name: Adel Aminian

I do not have any potential conflict of interest

Limitations of TR access?

« In case of complex PCI, I could not use large bore guide

catheters »

Sheath size and radial artery suitability

Saito et al CCI 2009

DOWNSIZING: THE FUTURE OF TRI !

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

CCI 2014;84:436-42

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

• 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

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

Individual-based approach for sheath selection

Procedural success RA patency

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

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

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

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

THANK YOU!

BACK UP SLIDES

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.

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)

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

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)