Sheathless Guide Catheters

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