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Trans-radial percutaneous coronary interventions using a 
Sheathless Eaucath guiding catheter compared to standard 
guiding catheter: a randomized study 
Tessitore E, Noble S, Gencer B, Rigamonti F, Bunwaree S, 
Righini M, Robert-Ebadi H, Roffi M. Bonvini RF 
AIM RADIAL - III 
Chicago - October 2014
Disclosure 
• Speaker honoraria for Cordis (radial workshop) 
• Proctor for Medtronic CoreValve
Background 
• The main limitations of TRA remain 
-the small size of the radial artery especially in 
women and elderly patients 
-the difficulty to use large bore guiding catheter 
for complex procedures (e.g. rotablation or 
complex left main distal bifurcation)
Background 
One potential solution is to use the Sheathless 
Eaucath GC (Asahi Intecc, Japan) which do not 
require any introducer sheath, thus reducing the 
equipment size within the RA lumen by ≈ 2-F sizes 
From S. Noble et al. Cardiovascular Medicine 2012;15(7-8):218-223
Sheathless Eaucath Guiding Catheter 
Asahi Intecc, Japan 
6.5 F 
7.5 F 
Specificity of the Sheathless GC inner diameter equivalent to conventional GC whereas 
the outer diameter is slighly inferior to that of a 6-F conventional introducer sheath for the 
7.5-F Sheathless GC and of a 5-F conventional introducer sheath for the 6.5-F
Hydrophylic coating and (radiotransparent) tapered central dilator which facilitates 
crossing RA & BA tortuosity as well as catheterisation of small caliber RA (< 2.5 mm) 
S. Noble et al. Cardiovascular Medicine 2012;15(7-8):218-223
Objective 
To compare in a radomized manner transradial 
PCI using Sheathless Eaucath GC to standard 
GC (Launcher Medtronic)
Methods 
The 6.5F Sheathless Eaucath GC was used in woman and 
the 7.5F Sheathless Eaucath GC in all patients with 
complex lesions requiring large bore GC. 
Performed at a single tertiary academic center by 3 trained 
radialists (MR, RB, SN) between January 2011 and May 
2013 
Routine administration of verapamil 2.5 mg, hemostasis 
using the TR band (Terumo) and dupplex scanning was 
planned at day 1
Methods 
Primary end points were 
 procedural success 
successful PCI without GC-induced coronary 
complications 
 procedural safety 
absence of hematoma, radial occlusion assessed 
by duplex scanning, PCI and vascular 
complications
Methods 
Secondary endpoint was the efficacy of the 
Sheathless Eaucath GC considering: 
-procedural time 
-amount of contrast media 
-cross-over to transfemoral approach or additional 
techniques (e.g. mother and child technique = telescoping for GC) 
5-F 125-cm long diagnostic catheter into 
a standard GC 
C. Frangos, S. Noble. Cardiovascular Medicine 2011;14(11):315-324
Baseline Characteristics (n=233)
Angiographic characteristics
Successful PCI and Complication rates 
Sheathless (114) Guiding catheter (119) 
Rate of complications 4 (3.5%) 3 (2.5%) 
No PCI complications were directly related to the GC type.
Vascular complications 
Rate of Dupplex scanning 
Dupplex was performed in 85% overall
Cross over 
233 PCI 
Sheathless 
114 
Crossover to 
GC+telescoping 
3 (2.7%) 
GC TF 
1 (0.9%) 
Success in 2/3 
(66.7%) 
No crossover 
111 (97.3%) 
Guiding 
119 
Crossover to 
Sheathless 
10 (8.4%) 
GC TF 
1 (0.8%) 
Success in 9 /10 
(90%) 
No crossover 
108 (91.6%) 
Conversion to TFapproach to perform PCI in this cohort of patients with 
successful diagnostic exam by transradial approach was < 1%
Use of Crossover or telescoping 
2.70% 
29.40% 
technique 
Sheatless Launcher guiding 
P value < 0.001 
Sheathless
Cross over + telescoping 
233 PCI 
Sheathless 
114 
Crossover 
3 (2.7%) 
GC+ telescoping 
2 (1.7%) 
GC TF 
1 (0.9%) 
No crossover 
111 (97.3%) 
Guiding 
119 
Crossover or 
telescoping* 
35 (29.4%) 
Telescoping 
35 (100%) 
Sheathless 
10 ( 28.6%) 
GC TF 
1 (10%) 
Telescoping 
success 25/35 
(71.4%) 
No crossover or 
telescoping 
84 (70.6%) 
*Failure while using telescoping in 10 patients out of 35
Subjective assessment of both technique
Conclusions 
• The use of Sheathless Eaucath GC in TR PCI was 
feasible, safe and effective compared to standard 
GC. 
• Crossover to Sheathless Eaucath GC after 
standard GC failure allowed successful TR PCI to 
be performed in most patients of the studied 
population (i.e. women, men requiring large bore 
GC).
Conclusions 
• Subjectively using a visual assessment scale 
- patients reported significantly less pain during 
sheathless catheter insertion than conventional 
guiding catheter 
-operators reported significantly easier arm 
crossability while using the sheathless catheters

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Tessitore E - AIMRADIAL 2014 - Sheathless

  • 1. Trans-radial percutaneous coronary interventions using a Sheathless Eaucath guiding catheter compared to standard guiding catheter: a randomized study Tessitore E, Noble S, Gencer B, Rigamonti F, Bunwaree S, Righini M, Robert-Ebadi H, Roffi M. Bonvini RF AIM RADIAL - III Chicago - October 2014
  • 2. Disclosure • Speaker honoraria for Cordis (radial workshop) • Proctor for Medtronic CoreValve
  • 3. Background • The main limitations of TRA remain -the small size of the radial artery especially in women and elderly patients -the difficulty to use large bore guiding catheter for complex procedures (e.g. rotablation or complex left main distal bifurcation)
  • 4. Background One potential solution is to use the Sheathless Eaucath GC (Asahi Intecc, Japan) which do not require any introducer sheath, thus reducing the equipment size within the RA lumen by ≈ 2-F sizes From S. Noble et al. Cardiovascular Medicine 2012;15(7-8):218-223
  • 5. Sheathless Eaucath Guiding Catheter Asahi Intecc, Japan 6.5 F 7.5 F Specificity of the Sheathless GC inner diameter equivalent to conventional GC whereas the outer diameter is slighly inferior to that of a 6-F conventional introducer sheath for the 7.5-F Sheathless GC and of a 5-F conventional introducer sheath for the 6.5-F
  • 6. Hydrophylic coating and (radiotransparent) tapered central dilator which facilitates crossing RA & BA tortuosity as well as catheterisation of small caliber RA (< 2.5 mm) S. Noble et al. Cardiovascular Medicine 2012;15(7-8):218-223
  • 7. Objective To compare in a radomized manner transradial PCI using Sheathless Eaucath GC to standard GC (Launcher Medtronic)
  • 8. Methods The 6.5F Sheathless Eaucath GC was used in woman and the 7.5F Sheathless Eaucath GC in all patients with complex lesions requiring large bore GC. Performed at a single tertiary academic center by 3 trained radialists (MR, RB, SN) between January 2011 and May 2013 Routine administration of verapamil 2.5 mg, hemostasis using the TR band (Terumo) and dupplex scanning was planned at day 1
  • 9. Methods Primary end points were  procedural success successful PCI without GC-induced coronary complications  procedural safety absence of hematoma, radial occlusion assessed by duplex scanning, PCI and vascular complications
  • 10. Methods Secondary endpoint was the efficacy of the Sheathless Eaucath GC considering: -procedural time -amount of contrast media -cross-over to transfemoral approach or additional techniques (e.g. mother and child technique = telescoping for GC) 5-F 125-cm long diagnostic catheter into a standard GC C. Frangos, S. Noble. Cardiovascular Medicine 2011;14(11):315-324
  • 13. Successful PCI and Complication rates Sheathless (114) Guiding catheter (119) Rate of complications 4 (3.5%) 3 (2.5%) No PCI complications were directly related to the GC type.
  • 14. Vascular complications Rate of Dupplex scanning Dupplex was performed in 85% overall
  • 15. Cross over 233 PCI Sheathless 114 Crossover to GC+telescoping 3 (2.7%) GC TF 1 (0.9%) Success in 2/3 (66.7%) No crossover 111 (97.3%) Guiding 119 Crossover to Sheathless 10 (8.4%) GC TF 1 (0.8%) Success in 9 /10 (90%) No crossover 108 (91.6%) Conversion to TFapproach to perform PCI in this cohort of patients with successful diagnostic exam by transradial approach was < 1%
  • 16. Use of Crossover or telescoping 2.70% 29.40% technique Sheatless Launcher guiding P value < 0.001 Sheathless
  • 17. Cross over + telescoping 233 PCI Sheathless 114 Crossover 3 (2.7%) GC+ telescoping 2 (1.7%) GC TF 1 (0.9%) No crossover 111 (97.3%) Guiding 119 Crossover or telescoping* 35 (29.4%) Telescoping 35 (100%) Sheathless 10 ( 28.6%) GC TF 1 (10%) Telescoping success 25/35 (71.4%) No crossover or telescoping 84 (70.6%) *Failure while using telescoping in 10 patients out of 35
  • 18. Subjective assessment of both technique
  • 19. Conclusions • The use of Sheathless Eaucath GC in TR PCI was feasible, safe and effective compared to standard GC. • Crossover to Sheathless Eaucath GC after standard GC failure allowed successful TR PCI to be performed in most patients of the studied population (i.e. women, men requiring large bore GC).
  • 20. Conclusions • Subjectively using a visual assessment scale - patients reported significantly less pain during sheathless catheter insertion than conventional guiding catheter -operators reported significantly easier arm crossability while using the sheathless catheters

Editor's Notes

  1. Dear colleague and mister chairman It is my pleasure to present on behalf of our team the result of the sheathless trial
  2. Here are my disclosures
  3. As you know the main limitations of transradial approch remain
  4. One potential solution is to use the sheathless Eaucath GC
  5. The specificity of the theses sheathless guiding catheter is that the inner diameter is equivalent to a regular Gc whereas the outer diameter of the 7.5 Fr is slightly inferior to that of a 6F conventional introducer sheath and for the 6.5 slighktly inferior to a 5F conventional introducer sheath The also have an hydrophylic caoting and a tapered central dilator whic facilitates crossing radial or brachial tortuosity as well as catheterising small caliber raidal arteries (< 2.5 mm)
  6. The objectove of the study was to compare transradial PCI with 6.5F and 7.5 F shethless eaucath GC respectively to standard GC in women and p
  7. The primary endpoint were menaning Procedural safety with the absence
  8. Among the 233 procedures as expected there was no significant difference between the 2 groups with respect to the baseline characteristics Mean age was around 69 yo 23 % of diabetic 40 to 50%were ACS patients
  9. Concerning the angiographic characteristics the location of lesion mainly in the lAD; the type of lesion and the procedural medications were similar There was only adifference in the catheter size. Significantly More guiding cateter for the 6F and significantly more sheathless for the 7.5 . This is explained by the fact that not all bifurcations lesions were performed using a 7F
  10. There were no différences in the rate of raidial occlusion which was around 3% in both groups There was 2 pseudo aneurysm And non difference with respect of the hematoma using the easy classification
  11. The rate of cross over was inferior in the sheathless group 2.7% vs 9.2% but that was not significant Conversion to TF to perform the PCI in this cohirt of patient with successful diagnostic exam by transradial approach was below 1%
  12. There is claerly a significant difference in favor of the sheathless arm when we include the cross over rate and the use of telescoping technique.
  13. by the operators showed significantly better crossability of the arm while using the sheathless guiding catheter, but no difference in the image quality back-up support and coronary cannulation difficulty Furthermore there was no differences in the timng ofr PCI, for cannulation and of fluoroscopy Subjective assement by the patients using a visual analgoue scale revealed less arm pain while using the sheatless cath And by the patient