This document discusses sheathless guide catheters as an alternative to traditional sheathed guide catheters for radial artery access. Sheathless guide catheters have smaller outer diameters than traditional sheaths, which may reduce complications. Asahi produces 6.5F and 7.5F sheathless guides that can be used for most PCI cases. MediKit also produces a 5F "virtual 3F" sheathless guide that may eliminate radial occlusion with short compression times, but has limitations for complex PCI and no means for prior angiography. Overall, sheathless guides show potential benefits but require further studies, especially for the 5F option.

1. Sheathless guide catheters
Douglas Fraser, MD
Manchester Heart Centre, UK

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner
have had no financial interest/arrangement or
affiliation relevant to this presentation

3. Outline
• Rationale
• Asahi sheathless Eaucath 6.5 7.5 8.5
• Medikit 5
• Home made

4. Cumulative frequency (%)
Radial artery lumen size
100
80
males
60 females
40
20
0
1.2 1.6 2.0 2.4 2.8 3.2 3.6 4.0 4.4
Inner diameter of Radial Artery (mm)
Saito S. CCI 1999

5. Sheath outer diameter / radial lumen
4F 5F 6F 7F 8F Sheaths
Cumulative frequency (%)
100
80
males
60 females
40
20
0
1.2 1.6 2.0 2.4 2.8 3.2 3.6 4.0 4.4
Inner diameter of Radial Artery (mm)
Saito S. CCI 1999

6. 100
Cumulative frequency (%) OD sheath 2F > guide
80 6F sheathless = 4F sheath
60
40 males
6F sheath females
20
0
1.2 1.6 2.0 2.4 2.8 3.2 3.6 4.0 4.4
100
Cumulative frequency (%)
80
60
40 6F sheathless males
20 females
0

7. Cumulative frequency (%)
100 7F sheathless = 5F
80 sheath
males
60 females
40
20 7F sheath
0
1.2 1.6 2.0 2.4 2.8 3.2 3.6 4.0 4.4
3
100
Cumulative frequency (%)
80
males
60 females
40
20 7F sheathless
0

8. OD sheath > radial lumen Radial occlusion / Pain
percent
slow flow sheath > radial lumen
14
13
14
12
10
RAID/SOD >1
8
RAID/SOD <1
6 4
4
2 0
0 Saito CCI 2001
all
All n=250 7F n=55
³7F
Arm pain greater if sheath
> 90% radial lumen
n=34
Gwon JIC 2006

9. Additional Consequences
Diffuse stenosis 22%
sheath > radial lumen
Sakai CCI 2001
Occlusion + Stenosis
50% failure after several
procedures
Nagai AJC 1999

10. Potential advantages
• Reduce radial occlusion / pain
• Enable use 6 / 7F guides small radial
• Reduce compression time

11. Asahi sheathless guide insertion

12. Asahi sheathless guides
• 6.5 F / 7.5F sheathless
– ID 6 / 7F conventional sheaths
– OD equivalent 4.5 / 5.5F sheath
• Insertion 0.035 wire / prior angio 4/5F sheath
– after 5F sheath - 6.5F sheathless saves 1F
- 7.5F sheathless saves 1.5F

13. Feasibility studies
• 6.5F routine PCI
– Mamas Fraser CCI 2009 success 100/100
• Casemix 25% primary PCI 40% NSTEMI
• 7.5F complex PCI
– Mamas Fraser CCI 2008 success 16/16
– Meguro TCT 2010 success 211/215
- 4 cannulation fail, tortuousity
• Well tolerated, can replace conventional guides
– learning curve re handling, catheter stiffness (tip dissection)

14. Angiography 5F spasm
2 vessel PCI
6.5F sheathless

15. Angiography 5F spasm
2 vessel PCI
6.5F sheathless

17. 7.5F sheathless

18. 7.5F
sheathless

19. Comparative study
• 542 consecutive patients – all comers
• Cohort 1 consecutive sheathless guides
6.5F, 7.5F
• Cohort 2 consecutive conventional guides
5, 6, 7 F
• Outcomes
– Procedural success
– Radial occlusion at 2 months
Unpublished data

20. Comparative Procedural outcomes
• Pain scores
– 6F conventional = 6.5F sheathless
– 7F conventional > 7.5F sheathless
• Radial occlusion
– conventional 4.4% = sheathless 3.7%
• Crossover
– conventional sheathless 5%

21. Why was radial occlusion not reduced ?
Conventional Sheathless (5F sheath)
No patients No patients 7.5F
6F 7F 6.5F
No patent haemostasis
Equipment size not reduced enough ?

22. Why was radial occlusion not reduced…
- would 4F have made a difference ?
Sheathless (4F sheath)
6.5F 7.5F

23. Going smaller…

24. MediKit 5F sheathless ‘virtual 3F’
Mizuno CCI
75:983-988
(2010)
True sheathless insertion
No solution for prior angiography

25. Would 5F sheathless make difference ?
Our data Yokoyama N. CCI 2000
5F sheathless 5F sheathless

26. Experience 5F sheathless
Case:
G Amoroso OLVG,Netherlands
exceptional permission

27. Case G Amoroso OLVG, exceptional permission

28. Case G Amoroso OLVG, exceptional permission

29. Short compression time
Removed compression after 1 hour

30. How feasible is 5F PCI
• Gobeil JIC 2004
– 216 RCT 5F vs 6F allcomers
– procedural success
• 5F 90%
• 6F 95%
– cross-over 5 to 6 F 8.6%

31. Will new equipment help ?
• Outside Japan
– IVUS
– Kissing balloon / anchor balloon
– Rotablation
– Guide catheter extensions
• Japan
– IVUS Terumo
– 0.010 wires, kissing balloon 5F
– 4in5 guide catheter extension

32. MediKit
Mizuno S. CCI 2010 : complex PCI
• success 24/27 cases 89%
• 3/27 crossover 6F 11%
• No radial occlusions

33. Home made 6F
• Dilator for
guiding sheath
• 110cm
diagnostic
catheter
• Guideliner 5in6
From et al CCI 2011
-success 10/11 cases
-coronary / renal PCI

34. Conclusions
• Asahi Eaucath – rational selective use
– 7.5F PCI requiring 7F - less pain 5%
– 6.5F small RA 5%
– disadvantages: catheter stiffness, cost
• MediKit 5F (use outside Japan awaited)
– true sheathless
– can eliminate radial occlusion, short compression ?
– not suitable all cases - 5F (new equipment may help)
– no solution prior angiography

35. Summary
• Asahi selective use
– 7.5F complex PCI
– 6.5F small radial
• MediKit 5F
– attractive option simple PCI
– studies required to confirm benefits