Radial approach: the volume-outcome relationship

1. Volume-Outcome Relationships
in Transradial PCI
Sunil V. Rao MD
The Duke Clinical Research Institute
The Durham VA Medical Center
Duke University Medical Center

2. Disclosures
• Consultant, Honoraria
• Astra Zeneca, The Medicines Company, Daiichi
Sankyo Lilly, Terumo Medical, Zoll
• Research funding
• Bellerophon
• Off-label uses of drugs/devices may be discussed

3. Volume-outcome and learning curve
• Volume-outcome relationship
• Volume-outcome in TRI
• Efficacy
• Safety
• Summary

4. Volume-outcome and learning curve
• Volume-outcome relationship
• Volume-outcome in TRI
• Efficacy
• Safety
• Summary

6. Volume-outcome relationship
N > 400,000 procedures 1974-1975; 1500 hospitals
Luft HS, Bunker JP, Enthoven AC. NEJM 1979

7. Volume-outcome and learning curve
• Volume-outcome relationship
• Volume-outcome in TRI
• Efficacy
• Safety
• Summary

8. Radial mega-analysis
N=76 studies (15 rand; 61 obs); 761,919 patients
Bertrand OF, et. al. AHJ 2012

9. Updated meta-analysis including RIVAL
Jolly SS, et. al. Lancet 2011
Radial
Better
Femoral
Better

10. RIVAL – Results stratified by site radial volume
*High (>146 radial PCI/year/ median operator at centre), Medium (61-146), Low (≤60)
No significant interaction by
Femoral PCI center volume
HR (95% CI) p-value
Interaction
0.25 1.00 4.00 16.00
Radial better Femoral better
High
Medium
Low
0.021
High
Medium
Low
0.013
High
Medium
Low
0.538
High
Medium
Low
0.003
Primary Outcome
Death, MI or stroke
Non CABG Major Bleed
Access site Cross-over
Jolly SS, et. al. Lancet 2011

11. Radial proficiency and radiation exposure
Radial Operator Volume
1200
900
600
300
0
Low Middle High
Radial
Femoral Jolly SS, et. al. JACC Intv 2013
Radial Center Volume
Air Kerma (mGy)
1500
1125
750
375
0
P=0.002
P=0.597
P=0.403
Low Middle High
P=0.304
P=0.680
P=0.007

12. “I would want the radial
approach by an experienced
person”
ACC Conversation with Experts, 2005 Clinical
Conversations Proceedings, p. 5
Robert Califf, MD
Duke University

13. Volume-outcome relationship and Learning Curve
Summary
• As described for other procedures, there is a
volume-outcome relationship for transradial
procedures
• Higher volume = better efficacy and safety
• Higher volume radial operators achieve the
benefits of transradial PCI
• These data support a “radial first” approach
• The number of procedures it takes to become
proficient (the learning curve) is the subject of the
next lecture