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RADIALISTS PERFORM BETTER
FEMORAL PCI
Jim Nolan
University Hospital of North Staffordshire
WHY DOESN’T EVERYBODY USE
RADIAL ACCESS
• Learning curve
• Extended Procedural duration
• Increased nursing input
• Patient preference
• Impaired Procedural success and applicability
• Increased cost of radial specific kit
• Radiation exposure
• If they do they will lose the ability to do safe TFA
RADIAL ENVIRONMENT
• Small calibre vessel
• Spasm risk
• Anatomical variation
• Advanced guide catheter techniques
• Skilled high volume TRA operators are
highly proficient interventionists ( as are
their teams )
FEMORAL ENVIRONMENT
FACTORS THAT MAY ACT TO INCREASE TFA
COMPLICATIONS IN RADIAL CENTERS
• Fewer TFA procedures
• Reduced exposure to technique for
operators in training and daily practice
• Reduced institutional experience with post
TFA care
ACCESS SITE PRACTICE EVOLUTION
IN THE UK
FACTORS THAT MAY ACT TO REDUCE TFA
COMPLICATIONS IN A RADIAL CENTER
•When a TRA operator has to perform a TFA
case it is done with maximum attention to
puncture, haemostasis and aftercare
•TRA operators performing TFA frequently
use guidance for the puncture
•Limited use of VCDs
VACD – DEVICE FAILURE RATE
(Sesana et-al, JIC 2000, n = 827)
9
11
0
2
4
6
8
10
12
COLLAGEN PLUG SUTURE
FAILURERATE(%)
VCD META ANALYSIS – RANDOMISED +
OBSERVATIONAL
(Nikolsky et-al, JACC 2004, n = 37,066)
COMPLICATIONS IN VCD MA
(Biancari et-al, Am Heart J 2010, n=7528)
HOW CAN WE INVESTIGATE THE
SAFETY OF TFA IN RADIAL
CENTERS
PATIENTS UNDERGOING PCI FROM
THE FEMORAL ROUTE BY DEFAULT
RADIAL OPERATORS
Ihsan M. Rafie, MD; Muez M. Uddin, MD; Nicholas Ossei-Gerning, MD; Richard A. Anderson, MD; Timothy D.
Kinnaird*, MD
Department of Cardiology, University Hospital of Wales, Cardiff, United Kingdom
Eurointervention 2014
CARDIFF STUDY
• 1352 PCI procedures performed by default
radial operators over 12 month period
• TFA used when operator felt it to be
technically and clinically appropriate ( skilled
TFA operators)
• ACUITY based definition of TFA related
complications ( included haematomas that
were not associated with Hb fall and required
no intervention)
• TFA utilised in 351 (25.2%) cases
WHAT TYPE OF PATIENT HAD TFA IN
THE CARDIFF STUDY
• Female gender (41% v 21%)
• Older (65 v 63)
• Lower BMI (80% v 84%)
• Shorter stature (167 v 171)
p < 0.001 for all comparisons
WHAT TYPE OF PROCEDURE WAS DONE
VIA TFA IN THE CARDIFF STUDY?
RESULTS IN TFA CASES
• 44 patients (12.5%) had femoral vascular
complication (ACUITY definition)
• 22 of these ( 6.25%) were haematomas with
no intervention required
• 22 (6,25%) had TFA complication that required
some form of intervention
The use of radial access decreases the risk of
vascular access-site-related complications at a
patient level but is associated with an
increased risk at a population level: the radial
paradox
Lorenzo Azzalini, MD, MSc; E. Marc Jolicoeur*, MD, MSc, MHS
Interventional Cardiology Division, Dept. of Medicine, Montreal Heart
Institute, Université de Montréal, Montréal, QC, Canada
INFLUENCE OF RADIAL ACCESS ON BLEEDING
AND VASCULAR COMPLICATIONS – META
ANALYSIS OF RANDOMISED TRIALS
(Jolly et-al,lancet,2011, n=10,000+)
META-ANALYSIS OF RCT COPARING RADIAL v FEMORAL
ACCESS IN STEMI PATIENTS UPDATED TO INCLUDE RIFLE
(Mamas et-al,Heart 2011,n=3978)
OR for mortality = 0.53 (95% CI 0.38-75); P<0.001 for radial
BRITISH CARDIOVASCULAR
INTERVENTION SOCIETY
• BCIS established in 1998 to promote and
monitor PCI activity in UK
• Collects data on all PCI performed in UK via
central electronic database ( 113 patient
,procedural and outcome variables )
• Robust mortality data using NHS number
• Linked to NHS central register
• Legal requirement for every death in UK to be
recorded
PCI OUTCOMES ACCORDING TO CLINICAL
SYNDROME AND ACCESS SITE
(n=433,000 JACCI 2014)
0.1 1
Favours TRA Favours TFA
Access site complication
0.20 (0.13-0.29) p<0.001
Bleed
0.53 (0.43-0.66) p<0.001
MACE
0.71 (0.65-0.78) p<0.001
30-Day Mortality
0.69 (0.62-0.77)
EMERGENCY
Access site complication
0.24 (0.19-0.30 p<0.001
Bleed
0.40 (0.31-0.52) p<0.001
MACE
0.85 (0.77-0.94) p<0.001
30-Day Mortality
0.85 (0.76-0.96) p=0.01
URGENT
Access site complication
0.22 (0.17-0.29) p<0.001
Bleed
0.24 (0.15-0.39) p<0.001
MACE
1.04 (0.92-1.18) p=0.53
30-Day Mortality
0.78 (0.57-1.03) p=0.77
STABLE
Figure 3. Forest plot of log odds ratio of outcomes following
multivariate logistic regression
Variables included in analysis: Age, sex, prior MI, prior CABG, prior PCI, diabetes,
hyperlidaemia, hypertension, peripheral vascular disease, previous stroke, smoking, pre-
procedural ventilation, use of circulatory support and pre-procedural shock.
UK BCIS PPCI
N=46,128
PPCI
39% TRA
TRA for PPCI
increased from
12% to 49%
Mamas M, JACC Cardiovasc Interv. 2013; 6: 698-706
TRM 2013
ACCES SITE RELATED OUTCOMES IN
CARDIOGENIC SHOCK
(AHJ,2014, n=7,231)
WHO STILL DOES TFA IN UK ?
GEOGRAPHICAL DISTRIBUTION OF
TRA IN UK
WHAT TYPE OF OPERATORS DO TFA IN UK?
Kinnaird T et al, O Heart 2014
CLOPIDOGREL USE IN STEMI PCI
UK FEMORAL OPERATORS
• Old guys based in south
• Low volume operators
• Slow to modify practice
EVALUATION OF TFA ACCESS SITE
PRACTICE IN MAJORITY RADIAL
CENTERS
• Years 2006 to 2010
• Single access site recorded
• TRA or TFA
P=0.007
P=0.26
P=0.6
ARE RADIAL CENTERS BETTER AT EVERYTHING?
WHAT DOES BCIS TELL US
• TRA benefits seen in RCT translate into
clinical practice
• Radial centers do better radial PCI
• No increase in TFA complications in radial
centers
• TFA procedures performed in a TRA center
were associated with an observed
reduction in mortality at 30 days
• In MVA OR 0.86, 95% CI 0.76-0.99,
p=0.032
Limitations
• Observational data
• Unmeasured confounders
• Data collected in an evolutionary period (operators
have TFA background)
• May not apply to TFA cases in very high volume TRA
centers ( case mix effects )
CONCLUSIONS
• Radial centres do better femoral PCI
• Radial centres do better radial PCI
• Radial centres do better PCI

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Radial PCI Associated With Lower Complication Rates

  • 1. RADIALISTS PERFORM BETTER FEMORAL PCI Jim Nolan University Hospital of North Staffordshire
  • 2. WHY DOESN’T EVERYBODY USE RADIAL ACCESS • Learning curve • Extended Procedural duration • Increased nursing input • Patient preference • Impaired Procedural success and applicability • Increased cost of radial specific kit • Radiation exposure • If they do they will lose the ability to do safe TFA
  • 3. RADIAL ENVIRONMENT • Small calibre vessel • Spasm risk • Anatomical variation • Advanced guide catheter techniques • Skilled high volume TRA operators are highly proficient interventionists ( as are their teams )
  • 5. FACTORS THAT MAY ACT TO INCREASE TFA COMPLICATIONS IN RADIAL CENTERS • Fewer TFA procedures • Reduced exposure to technique for operators in training and daily practice • Reduced institutional experience with post TFA care
  • 6. ACCESS SITE PRACTICE EVOLUTION IN THE UK
  • 7. FACTORS THAT MAY ACT TO REDUCE TFA COMPLICATIONS IN A RADIAL CENTER •When a TRA operator has to perform a TFA case it is done with maximum attention to puncture, haemostasis and aftercare •TRA operators performing TFA frequently use guidance for the puncture •Limited use of VCDs
  • 8. VACD – DEVICE FAILURE RATE (Sesana et-al, JIC 2000, n = 827) 9 11 0 2 4 6 8 10 12 COLLAGEN PLUG SUTURE FAILURERATE(%)
  • 9. VCD META ANALYSIS – RANDOMISED + OBSERVATIONAL (Nikolsky et-al, JACC 2004, n = 37,066)
  • 10. COMPLICATIONS IN VCD MA (Biancari et-al, Am Heart J 2010, n=7528)
  • 11. HOW CAN WE INVESTIGATE THE SAFETY OF TFA IN RADIAL CENTERS
  • 12. PATIENTS UNDERGOING PCI FROM THE FEMORAL ROUTE BY DEFAULT RADIAL OPERATORS Ihsan M. Rafie, MD; Muez M. Uddin, MD; Nicholas Ossei-Gerning, MD; Richard A. Anderson, MD; Timothy D. Kinnaird*, MD Department of Cardiology, University Hospital of Wales, Cardiff, United Kingdom Eurointervention 2014
  • 13. CARDIFF STUDY • 1352 PCI procedures performed by default radial operators over 12 month period • TFA used when operator felt it to be technically and clinically appropriate ( skilled TFA operators) • ACUITY based definition of TFA related complications ( included haematomas that were not associated with Hb fall and required no intervention) • TFA utilised in 351 (25.2%) cases
  • 14. WHAT TYPE OF PATIENT HAD TFA IN THE CARDIFF STUDY • Female gender (41% v 21%) • Older (65 v 63) • Lower BMI (80% v 84%) • Shorter stature (167 v 171) p < 0.001 for all comparisons
  • 15. WHAT TYPE OF PROCEDURE WAS DONE VIA TFA IN THE CARDIFF STUDY?
  • 16. RESULTS IN TFA CASES • 44 patients (12.5%) had femoral vascular complication (ACUITY definition) • 22 of these ( 6.25%) were haematomas with no intervention required • 22 (6,25%) had TFA complication that required some form of intervention
  • 17. The use of radial access decreases the risk of vascular access-site-related complications at a patient level but is associated with an increased risk at a population level: the radial paradox Lorenzo Azzalini, MD, MSc; E. Marc Jolicoeur*, MD, MSc, MHS Interventional Cardiology Division, Dept. of Medicine, Montreal Heart Institute, Université de Montréal, Montréal, QC, Canada
  • 18. INFLUENCE OF RADIAL ACCESS ON BLEEDING AND VASCULAR COMPLICATIONS – META ANALYSIS OF RANDOMISED TRIALS (Jolly et-al,lancet,2011, n=10,000+)
  • 19. META-ANALYSIS OF RCT COPARING RADIAL v FEMORAL ACCESS IN STEMI PATIENTS UPDATED TO INCLUDE RIFLE (Mamas et-al,Heart 2011,n=3978) OR for mortality = 0.53 (95% CI 0.38-75); P<0.001 for radial
  • 20. BRITISH CARDIOVASCULAR INTERVENTION SOCIETY • BCIS established in 1998 to promote and monitor PCI activity in UK • Collects data on all PCI performed in UK via central electronic database ( 113 patient ,procedural and outcome variables ) • Robust mortality data using NHS number • Linked to NHS central register • Legal requirement for every death in UK to be recorded
  • 21. PCI OUTCOMES ACCORDING TO CLINICAL SYNDROME AND ACCESS SITE (n=433,000 JACCI 2014) 0.1 1 Favours TRA Favours TFA Access site complication 0.20 (0.13-0.29) p<0.001 Bleed 0.53 (0.43-0.66) p<0.001 MACE 0.71 (0.65-0.78) p<0.001 30-Day Mortality 0.69 (0.62-0.77) EMERGENCY Access site complication 0.24 (0.19-0.30 p<0.001 Bleed 0.40 (0.31-0.52) p<0.001 MACE 0.85 (0.77-0.94) p<0.001 30-Day Mortality 0.85 (0.76-0.96) p=0.01 URGENT Access site complication 0.22 (0.17-0.29) p<0.001 Bleed 0.24 (0.15-0.39) p<0.001 MACE 1.04 (0.92-1.18) p=0.53 30-Day Mortality 0.78 (0.57-1.03) p=0.77 STABLE Figure 3. Forest plot of log odds ratio of outcomes following multivariate logistic regression Variables included in analysis: Age, sex, prior MI, prior CABG, prior PCI, diabetes, hyperlidaemia, hypertension, peripheral vascular disease, previous stroke, smoking, pre- procedural ventilation, use of circulatory support and pre-procedural shock.
  • 22. UK BCIS PPCI N=46,128 PPCI 39% TRA TRA for PPCI increased from 12% to 49% Mamas M, JACC Cardiovasc Interv. 2013; 6: 698-706 TRM 2013
  • 23. ACCES SITE RELATED OUTCOMES IN CARDIOGENIC SHOCK (AHJ,2014, n=7,231)
  • 24. WHO STILL DOES TFA IN UK ?
  • 26. WHAT TYPE OF OPERATORS DO TFA IN UK? Kinnaird T et al, O Heart 2014
  • 27. CLOPIDOGREL USE IN STEMI PCI
  • 28. UK FEMORAL OPERATORS • Old guys based in south • Low volume operators • Slow to modify practice
  • 29. EVALUATION OF TFA ACCESS SITE PRACTICE IN MAJORITY RADIAL CENTERS • Years 2006 to 2010 • Single access site recorded • TRA or TFA
  • 31. ARE RADIAL CENTERS BETTER AT EVERYTHING?
  • 32. WHAT DOES BCIS TELL US • TRA benefits seen in RCT translate into clinical practice • Radial centers do better radial PCI • No increase in TFA complications in radial centers • TFA procedures performed in a TRA center were associated with an observed reduction in mortality at 30 days • In MVA OR 0.86, 95% CI 0.76-0.99, p=0.032
  • 33. Limitations • Observational data • Unmeasured confounders • Data collected in an evolutionary period (operators have TFA background) • May not apply to TFA cases in very high volume TRA centers ( case mix effects )
  • 34. CONCLUSIONS • Radial centres do better femoral PCI • Radial centres do better radial PCI • Radial centres do better PCI

Editor's Notes

  1. over 46 thousand PPCI procedures with a documented single access site overall 39% TRA....Increased from 12 % to almost 50% over 4 years Those done radially had better MACE free survival as illustrated in the unadjusted kaplan meier curve here