Impact of Learning Curves on Clinical
Outcomes in the US
Robert J Applegate, M.D.
Professor of Internal Medicine-Cardiology
Disclosures

Advisory Board Abbott Vascular
Research Grants Abbott Vascular
St Jude Medical
Consultant
Abbott Vascular

Serruys, PW. PCR 2010

Wake Forest School of Medicine

AIM Radial 2013
The learning curve for radial artery procedures:
historical perspective

No differences in primary entry site complications, or
MACE, but “there was a clear trend toward more
technical difficulties and more problems with the radial
approach.”
Wake Forest School of Medicine

AIM Radial 2013
The learning curve for radial artery procedures:
historical perspective

“In conclusion, it is evident, when reviewing
this study, that the difficulties associated with
the learning curve must be overcome
before a randomized study can be carried
out.”

Wake Forest School of Medicine

AIM Radial 2013
Radial “learning curve” identified early on with
attempts to quantify the “steepness” of the curve

Inflection ??

Plateau ??

Wake Forest School of Medicine

Spaulding et al: CCI 1996; 39:365-370

AIM Radial 2013
The word in the US Interventional World
The first person to describe the learning curve was Hermann Ebbinghaus in 1885, in the
field of the psychology of learning

is that the radial learning curve is “steep”
But is that really true?

Radial ??

Radial ??

Radial ??

Wake Forest School of Medicine

AIM Radial 2013
The learning curve for radial artery procedures:
Quantifying the curve and
Linking the learning curve to outcomes
•

Complex interaction of factors that influence the learning curve:
Operator and center experience and volume; presence of fellows
Cath lab tolerance for ramp up, longer cases if needed
Case mix including STEMI, graft cases

•

Metrics to define the curve include both procedural process metrics
(eg floro time) as well as traditional patient outcomes(eg access
complication rates); not uniformly accepted standards

• Data establishing causality between individual learning curve
procedural process metric and patient outcome metric are lacking

Wake Forest School of Medicine

AIM Radial 2013
Recent worldwide data on
The learning curve for radial artery procedures:
RIVAL Trial data

Wake Forest School of Medicine

Jolly et al; JACC CI 2013; 6:258-66

AIM Radial 2013
Recent worldwide data on
The learning curve for radial artery procedures:
RIVAL Trial data
Center center
Operator air kerma
Operator andVolume volumes associated with lowerVolume
Interaction between operator and center volumes remains to be
fully elucidated

Wake Forest School of Medicine

Jolly et al; JACC CI 2013; 6:258-66

AIM Radial 2013
Recent worldwide data on
The learning curve for radial artery procedures:
Registry data
(Dedicated radialist)
(Standard radialist)

Case volume affects failure rate
Both low and high volume operators
continue to improve over time
Both p<0.05 vs
2005-2006

Wake Forest School of Medicine

Burzotta et al AHJ 2012; 163:230-238

AIM Radial 2013
The US experience of radial artery procedures:
NCDR CATH/PCI Registry data

Wake Forest School of Medicine

Feldman et al; Circ 2013; 127:2295-2306

AIM Radial 2013
The US experience of radial artery procedures:
NCDR CATH/PCI Registry data

16.1% 3rd Q 2012

Wake Forest School of Medicine

Feldman et al; Circ 2013; 127:2295-2306

AIM Radial 2013
The US learning curve for radial artery procedures:
Wake Forest Registry data

Wake Forest School of Medicine

Turner et al; CCI 2012; 80:247-257

AIM Radial 2013
The US learning curve for radial artery procedures:
Wake Forest Registry data

Wake Forest School of Medicine

Turner et al; CCI 2012; 80:247-257

AIM Radial 2013
The US learning curve for radial artery procedures:
Wake Forest Registry data

Transition to preferred radial approach resulted in
better patient centered outcomes including lower
access site and bleeding complications

Wake Forest School of Medicine

Turner et al; CCI 2012; 80:247-257

AIM Radial 2013
The US learning curve for radial artery procedures:
Wake Forest Registry data
Radial artery access metrics by period

Metric

Transition
Radial
(N = 610)

Preferred TR
Radial
(N = 897)

7 (5-10)
26 (20-36)
66 (51-85)
50 (38-71)

6 (4-9) *
24 (19-34) *
64 (53-83)
49 (40-52)

7 (5-12)
21 (16-30)
16 (10-24)

7 (5-11) *
21 (15-27)
14 (10-19)

76 (56-98)
190 (147-250)
132 (86-191)

74 (55-99)
194 (142-246)
111 (92-122)

Generalized decrease in procedural metrics with
Access site crossover, n (%)
80 (8.9%)
reduced inter quartile ranges 57 (9.3%)
Sheath size, Fr
CATH only
5.0 (0.2)
5.0 (0.1)
Efforts to quantify learning curve(0.4)
PCI
6.0 complicated by *
5.7 (0.5)
Procedure time intervals, minutes
affectinsertion
Sheath of new fellows on monthly basis
5 (3-10)
5 (3-9) *
Intubate coronaries
Total procedure, CATH only
Total procedure, CATH + PCI
Total procedure, PCI only
Fluoroscopy time, minutes
CATH only
CATH + PCI
PCI only
Contrast volume used, mL
CATH only
CATH + PCI
PCI only
Wake Forest School of Medicine

Turner et al; CCI 2012; 80:247-257

AIM Radial 2013
The US learning curve for radial artery procedures:
Wake Forest Registry data
Radial artery access metrics by period for operators with highest and lowest proportion of radial artery access
Attending A (HIGH)
Attending B (LOW)
Transition
Preferred TR
Transition
Preferred TR
Metric
(N = 350)
(N = 329)
(N = 272)
(N = 277)
Radial artery access, n / total volume (%)
Access site crossover, n / TR volume (%)
TR procedure time intervals, minutes
Sheath insertion
Intubate coronaries
Total procedure, CATH only
Total procedure, CATH + PCI
Total procedure, PCI only
TR fluoroscopy time, minutes
CATH only
CATH + PCI
PCI only
TR contrast volume used, mL
CATH only
CATH + PCI
PCI only

202/350 (58%)
12/202 (6%)

233/329 (71%) †
12/233 (5%)

93/272 (34%) ‡
15/93 (16%) ‡

171/277 (62%) †‡
18/171 (11%) ‡

6 (4-11)
6 (4-8)
24 (17-33)
61 (47-74)
50 (43-62)

6 (3-10)
5 (4-7) †
20 (16-28) †
53 (41-66) †
51 (28-52)

6 (4-8)
8 (5-13) ‡
29 (21-37) ‡
72 (52-95)
39 (36-41)

5 (3-9) ‡
6 (5-9) †‡
25 (21-35) ‡
68 (59-89) ‡
40 (40-40)

Similar to Burzotta found a volume – outcome
relationship among both higher and lower
5 (4-8)
5 (3-7) †
9 (6-15) ‡
8 (6-13) ‡
18 (12-26)
15 (11-19)
26 (20-39) ‡
22 (16-29) ‡
volume operators†
14 (10-23)
16 (10-19)
23 (21-24)
12 (12-12)
61 (50-83)
141 (106-176)
95 (74-177)

65 (43-83)
141 (119-180)
105 (30-122)

76 (50-98) ‡
191 (153-253) ‡
150 (109-190)

74 (60-91) ‡
197 (149-231) ‡
92 (92-92)

† p<0.05 vs Transition, ‡ p<0.05 vs Attending A. CATH indicates diagnostic catheterization; PCI, percutaneous coronary intervention.

Wake Forest School of Medicine

Unpublished observations

AIM Radial 2013
The US learning curve for radial artery procedures:
Vanderbilt Registry data

Wake Forest School of Medicine

Kasasbeh et al; JIC 2012; 24:599-604

AIM Radial 2013
The US learning curve for radial artery procedures:
Vanderbilt Registry data

60% radial

Wake Forest School of Medicine

Kasasbeh et al; JIC 2012; 24:599-604

AIM Radial 2013
Floro time (min)

The US learning curve for radial artery procedures:
Vanderbilt Registry data

Procedure time (min)

Room time (min)

Incorporation of radial access to our cardiac
catheterization laboratory led to a decrease in
fluoroscopy time in each operator, operator
group, and institute-wide over the last 3 years.
This improvement was seen after
approximately 25 cases and further improved
after 75 cases.

Wake Forest School of Medicine

Kasasbeh et al; JIC 2012; 24:599-604

AIM Radial 2013
The US learning curve for radial artery procedures:
NCDR

Wake Forest School of Medicine

Hess et al; ACC 2013

AIM Radial 2013
The US learning curve for radial artery procedures:
NCDR

Wake Forest School of Medicine

Hess et al; ACC 2013

AIM Radial 2013
The US learning curve for radial artery procedures:
NCDR

More complex cases performed by
higher volume operators

Wake Forest School of Medicine

Hess et al; ACC 2013

AIM Radial 2013
The US learning curve for radial artery procedures:
NCDR

Procedural metrics reduced by
higher volume operators

Wake Forest School of Medicine

Hess et al; ACC 2013

AIM Radial 2013
The US learning curve for radial artery procedures:
NCDR

Wake Forest School of Medicine

Hess et al; ACC 2013

AIM Radial 2013
The US learning curve for radial artery procedures:
NCDR

Wake Forest School of Medicine

Hess et al; ACC 2013

AIM Radial 2013
Impact of Learning Curves on Clinical
Outcomes in the US- Summary
• Recent data indicate that the radial learning curve may not be as
“steep” as once believed
• Threshold for initial “competence” 25-40 cases
•
•

Improvement continues with greater experience consistent with
a volume-outcomes interaction
Learning curve may be influenced by practice setting, eg academic
vs non-academic

• Procedural metrics are easily measured but are influenced by
multiple factors making interpretation challenging, and linkage
to outcomes difficult.

• Nonetheless, these data suggest that radial adoption is occurring
quickly and efficiently while achieving a better safety profile
than femoral artery procedures
Wake Forest School of Medicine

AIM Radial 2013

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Applegate RJ - AIMRADIAL 2013 - Learning curve

  • 1. Impact of Learning Curves on Clinical Outcomes in the US Robert J Applegate, M.D. Professor of Internal Medicine-Cardiology
  • 2. Disclosures Advisory Board Abbott Vascular Research Grants Abbott Vascular St Jude Medical Consultant Abbott Vascular Serruys, PW. PCR 2010 Wake Forest School of Medicine AIM Radial 2013
  • 3. The learning curve for radial artery procedures: historical perspective No differences in primary entry site complications, or MACE, but “there was a clear trend toward more technical difficulties and more problems with the radial approach.” Wake Forest School of Medicine AIM Radial 2013
  • 4. The learning curve for radial artery procedures: historical perspective “In conclusion, it is evident, when reviewing this study, that the difficulties associated with the learning curve must be overcome before a randomized study can be carried out.” Wake Forest School of Medicine AIM Radial 2013
  • 5. Radial “learning curve” identified early on with attempts to quantify the “steepness” of the curve Inflection ?? Plateau ?? Wake Forest School of Medicine Spaulding et al: CCI 1996; 39:365-370 AIM Radial 2013
  • 6. The word in the US Interventional World The first person to describe the learning curve was Hermann Ebbinghaus in 1885, in the field of the psychology of learning is that the radial learning curve is “steep” But is that really true? Radial ?? Radial ?? Radial ?? Wake Forest School of Medicine AIM Radial 2013
  • 7. The learning curve for radial artery procedures: Quantifying the curve and Linking the learning curve to outcomes • Complex interaction of factors that influence the learning curve: Operator and center experience and volume; presence of fellows Cath lab tolerance for ramp up, longer cases if needed Case mix including STEMI, graft cases • Metrics to define the curve include both procedural process metrics (eg floro time) as well as traditional patient outcomes(eg access complication rates); not uniformly accepted standards • Data establishing causality between individual learning curve procedural process metric and patient outcome metric are lacking Wake Forest School of Medicine AIM Radial 2013
  • 8. Recent worldwide data on The learning curve for radial artery procedures: RIVAL Trial data Wake Forest School of Medicine Jolly et al; JACC CI 2013; 6:258-66 AIM Radial 2013
  • 9. Recent worldwide data on The learning curve for radial artery procedures: RIVAL Trial data Center center Operator air kerma Operator andVolume volumes associated with lowerVolume Interaction between operator and center volumes remains to be fully elucidated Wake Forest School of Medicine Jolly et al; JACC CI 2013; 6:258-66 AIM Radial 2013
  • 10. Recent worldwide data on The learning curve for radial artery procedures: Registry data (Dedicated radialist) (Standard radialist) Case volume affects failure rate Both low and high volume operators continue to improve over time Both p<0.05 vs 2005-2006 Wake Forest School of Medicine Burzotta et al AHJ 2012; 163:230-238 AIM Radial 2013
  • 11. The US experience of radial artery procedures: NCDR CATH/PCI Registry data Wake Forest School of Medicine Feldman et al; Circ 2013; 127:2295-2306 AIM Radial 2013
  • 12. The US experience of radial artery procedures: NCDR CATH/PCI Registry data 16.1% 3rd Q 2012 Wake Forest School of Medicine Feldman et al; Circ 2013; 127:2295-2306 AIM Radial 2013
  • 13. The US learning curve for radial artery procedures: Wake Forest Registry data Wake Forest School of Medicine Turner et al; CCI 2012; 80:247-257 AIM Radial 2013
  • 14. The US learning curve for radial artery procedures: Wake Forest Registry data Wake Forest School of Medicine Turner et al; CCI 2012; 80:247-257 AIM Radial 2013
  • 15. The US learning curve for radial artery procedures: Wake Forest Registry data Transition to preferred radial approach resulted in better patient centered outcomes including lower access site and bleeding complications Wake Forest School of Medicine Turner et al; CCI 2012; 80:247-257 AIM Radial 2013
  • 16. The US learning curve for radial artery procedures: Wake Forest Registry data Radial artery access metrics by period Metric Transition Radial (N = 610) Preferred TR Radial (N = 897) 7 (5-10) 26 (20-36) 66 (51-85) 50 (38-71) 6 (4-9) * 24 (19-34) * 64 (53-83) 49 (40-52) 7 (5-12) 21 (16-30) 16 (10-24) 7 (5-11) * 21 (15-27) 14 (10-19) 76 (56-98) 190 (147-250) 132 (86-191) 74 (55-99) 194 (142-246) 111 (92-122) Generalized decrease in procedural metrics with Access site crossover, n (%) 80 (8.9%) reduced inter quartile ranges 57 (9.3%) Sheath size, Fr CATH only 5.0 (0.2) 5.0 (0.1) Efforts to quantify learning curve(0.4) PCI 6.0 complicated by * 5.7 (0.5) Procedure time intervals, minutes affectinsertion Sheath of new fellows on monthly basis 5 (3-10) 5 (3-9) * Intubate coronaries Total procedure, CATH only Total procedure, CATH + PCI Total procedure, PCI only Fluoroscopy time, minutes CATH only CATH + PCI PCI only Contrast volume used, mL CATH only CATH + PCI PCI only Wake Forest School of Medicine Turner et al; CCI 2012; 80:247-257 AIM Radial 2013
  • 17. The US learning curve for radial artery procedures: Wake Forest Registry data Radial artery access metrics by period for operators with highest and lowest proportion of radial artery access Attending A (HIGH) Attending B (LOW) Transition Preferred TR Transition Preferred TR Metric (N = 350) (N = 329) (N = 272) (N = 277) Radial artery access, n / total volume (%) Access site crossover, n / TR volume (%) TR procedure time intervals, minutes Sheath insertion Intubate coronaries Total procedure, CATH only Total procedure, CATH + PCI Total procedure, PCI only TR fluoroscopy time, minutes CATH only CATH + PCI PCI only TR contrast volume used, mL CATH only CATH + PCI PCI only 202/350 (58%) 12/202 (6%) 233/329 (71%) † 12/233 (5%) 93/272 (34%) ‡ 15/93 (16%) ‡ 171/277 (62%) †‡ 18/171 (11%) ‡ 6 (4-11) 6 (4-8) 24 (17-33) 61 (47-74) 50 (43-62) 6 (3-10) 5 (4-7) † 20 (16-28) † 53 (41-66) † 51 (28-52) 6 (4-8) 8 (5-13) ‡ 29 (21-37) ‡ 72 (52-95) 39 (36-41) 5 (3-9) ‡ 6 (5-9) †‡ 25 (21-35) ‡ 68 (59-89) ‡ 40 (40-40) Similar to Burzotta found a volume – outcome relationship among both higher and lower 5 (4-8) 5 (3-7) † 9 (6-15) ‡ 8 (6-13) ‡ 18 (12-26) 15 (11-19) 26 (20-39) ‡ 22 (16-29) ‡ volume operators† 14 (10-23) 16 (10-19) 23 (21-24) 12 (12-12) 61 (50-83) 141 (106-176) 95 (74-177) 65 (43-83) 141 (119-180) 105 (30-122) 76 (50-98) ‡ 191 (153-253) ‡ 150 (109-190) 74 (60-91) ‡ 197 (149-231) ‡ 92 (92-92) † p<0.05 vs Transition, ‡ p<0.05 vs Attending A. CATH indicates diagnostic catheterization; PCI, percutaneous coronary intervention. Wake Forest School of Medicine Unpublished observations AIM Radial 2013
  • 18. The US learning curve for radial artery procedures: Vanderbilt Registry data Wake Forest School of Medicine Kasasbeh et al; JIC 2012; 24:599-604 AIM Radial 2013
  • 19. The US learning curve for radial artery procedures: Vanderbilt Registry data 60% radial Wake Forest School of Medicine Kasasbeh et al; JIC 2012; 24:599-604 AIM Radial 2013
  • 20. Floro time (min) The US learning curve for radial artery procedures: Vanderbilt Registry data Procedure time (min) Room time (min) Incorporation of radial access to our cardiac catheterization laboratory led to a decrease in fluoroscopy time in each operator, operator group, and institute-wide over the last 3 years. This improvement was seen after approximately 25 cases and further improved after 75 cases. Wake Forest School of Medicine Kasasbeh et al; JIC 2012; 24:599-604 AIM Radial 2013
  • 21. The US learning curve for radial artery procedures: NCDR Wake Forest School of Medicine Hess et al; ACC 2013 AIM Radial 2013
  • 22. The US learning curve for radial artery procedures: NCDR Wake Forest School of Medicine Hess et al; ACC 2013 AIM Radial 2013
  • 23. The US learning curve for radial artery procedures: NCDR More complex cases performed by higher volume operators Wake Forest School of Medicine Hess et al; ACC 2013 AIM Radial 2013
  • 24. The US learning curve for radial artery procedures: NCDR Procedural metrics reduced by higher volume operators Wake Forest School of Medicine Hess et al; ACC 2013 AIM Radial 2013
  • 25. The US learning curve for radial artery procedures: NCDR Wake Forest School of Medicine Hess et al; ACC 2013 AIM Radial 2013
  • 26. The US learning curve for radial artery procedures: NCDR Wake Forest School of Medicine Hess et al; ACC 2013 AIM Radial 2013
  • 27. Impact of Learning Curves on Clinical Outcomes in the US- Summary • Recent data indicate that the radial learning curve may not be as “steep” as once believed • Threshold for initial “competence” 25-40 cases • • Improvement continues with greater experience consistent with a volume-outcomes interaction Learning curve may be influenced by practice setting, eg academic vs non-academic • Procedural metrics are easily measured but are influenced by multiple factors making interpretation challenging, and linkage to outcomes difficult. • Nonetheless, these data suggest that radial adoption is occurring quickly and efficiently while achieving a better safety profile than femoral artery procedures Wake Forest School of Medicine AIM Radial 2013