5 in 6 study Delivery Success Rate of 5 in 6 system

1
5 in 6 studyDelivery Success Rate of 5 in 6
system

• Shonan Kamakura General Hospital
• SaEhKo
• Shigeru Saito

2
Background

• 6 French guiding catheter is commonly used
• in coronary interventions.
• However the backup support is 6F guiding
• catheter is not strong as 7 or 8F guiding
• catheter.
• And one of the reason of unsuccessful coronary
• interventions is the delivery failure of the
  devices
• because of its poor backup support.

3
Background

• 5 in 6 system is expected to create stronger
• backup support to get successful interventions.

4
In-vitro measurements of backup support
Plt0.0001
Backup support (gf)
8F alone
7F alone
6F alone
5 in 6 (0mm)
5 in 6 (15mm)
5 in 6 (10mm)
5 in 6 (5mm)
Guiding Catheter
System
5
Purpose of 5 in 6 study

• The purpose of this study
• is
• to evaluate
• the efficacy of 5 in 6 system
• in a real world.

6
5 in 6 study

• Study Design
• non-randomized
• multi-center open trial
• Numbers of centers
• 38 Hospitals in Japan
• Duration
• April 10, 2003October 31, 2003

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The procedure of 5 in 6 study

• 6F system coronary intervention

delivery success of the device
delivery failure of the device
Study Entry
5 in 6 system
delivery success of the device in 5 in 6
system
delivery failure of device in 5 in 6 system
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End Point

• Delivery success of any device
• in 5 in 6 system
• guidewire
• balloon catheter
• stent
• IVUS

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Results

• Entry Numbers 48
• Delivery Success Rate
• of 5 in 6 system
• 87.5 (42/48)
• Success Rate of the interventions
• 83.3(40/48)

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Patients characteristics

• Success Failure
• Numbers 42
  6
• Age (years) 70.011.7 66.010.8
• Male 29 (69.0) 6
  (100)
• AP 25 (59.5) 2
  (33.3)
• OMI 16 (38.1) 3
  (50.0)
• AMI 1 (2.4) 1
  (1.7)
• DM 12 (28.6) 3
  (50.0)
• HT 21 (50.0) 4
  (66.7)
• HL 14 (33.3) 2
  (33.3)

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Lesion Characteristics

• 
  Success Failure
• Length(mm) 17.67.6
  13.35.2
• Vessel diameter(mm) 2.70.8 2.50.5
• Stenosis() 94.68.0
  94.85.3

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Which Device
13
Coronary artery branch
14
TRI vs TFI
15
Guiding catheter
16
AHA type
17
TIMI flow
18
Lesion morphology
19
For CTO and non-CTO
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CTO

• Duration of CTO
• Success failure
• 5.90.7month 4.32.9month

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Complication

• 1 Air Emboli

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Discussion

• Because of small numbers of cases,
• there was no any statistical difference
• between the delivery success and the
• failure of 5 in 6 system.
• (we need more cases!)
• But this means.

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Discussion

• There is no limitation
• the use of 5 in 6 system.
• You can try it for any lesions
• and in any background.

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Discussion

• Without 5 in 6 system
• 40cases (83.3)
• coronary interventions
• could be failed because of
• the delivery failure of the device

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Conclusion

• High success rate
• Less Complication
• Simple procedure
• 5 in 6 system is a worth trying
• strategy!