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TransRadial PCI: Advantages, Disadvantages,     and Uptake in the U.S. and Abroad   TransRadial Education & Training & The...
Presenter Disclosure InformationDavid R. Holmes, Jr., M.D.“TransRadial PCI: Advantages, Disadvantages, and Uptake in the U...
Radial Approaches         Issues• What are the advantages• Does this approach deliver?• What are the issues in delivering ...
Transfemoral Approach•   Dominant strategy since Dr Melvin Judkins•   Large vessels•   Preformed catheters•   Avoided cutd...
Transfemoral Approach•   Entry site critical•   Landmarks sometimes very problematic•   The Red Sea•   Space for unrecogni...
Advantage and Disadvantages               of Transradial Approach to PCI    Advantages      • Reduced bleeding risk      •...
Normal Radial Artery AnatomyHeart 95:410, 2009
Radial Approaches• Improved patient safety• Patient comfort – preference• Simplified post-procedural care• Decreased lengt...
Radial vs Femoral AccessSystematic Review and Meta Analysis• 23 randomized trials with 7,020 patients undergoing angiograp...
Radial vs Femoral Access    Systematic Review and Meta AnalysisEndpoints (%)             Radial Femoral           OR      ...
Radial vs Femoral AccessSystematic Review and Meta Analysis Conclusions: Radial access reduced major bleeding and there wa...
3050029-12
Radial Approaches        Issues• Physical set up – arm board• Radial anomalies• Learning curve• LIMA• Radiation exposure
Transradial approach•   How do you introduce it?•   Ergonomics and radiation exposure•   Ergonomics and Left-Right•   Prio...
Radial Artery Anomalies  • 1,540 consecutive patients undergoing first    transradial procedure – angio + PCI  • Retrograd...
Radial Artery Anomalies              Clinical characteristics              Mean age (yr)              63.6              M/...
Radial Artery Anomalies                          1,540 patients                  13.8% anomalies (212 patients)           ...
Complex Large Radial Artery LoopsHeart 95:410, 2009
Radial Artery Loop               “Crossing”         StraighteningHeart 95:410, 2009
High-Bifurcating Radial Artery that Rejoins the Brachial Artery at the Middle Third of the HumerusHeart 95:410, 2009
Extreme Radial Artery TortuosityHeart 95:410, 2009
Radial Artery Anatomy and Procedural Outcome      100                        Normal radial anatomy (n=1,321)              ...
Types of Radial Anomaly and             Their Rates of Procedural Failure      120                                        ...
High-Bifurcating Radial Artery             Anastomosis Sites and Diameters              Anastomosis Sites                 ...
Radial Artery Anomalies  Procedural failure        14.2 vs 0.9% P<0.001  anomaly vs not  High-radial bifurcation      4.6%...
Advantage and Disadvantages               of Transradial Approach to PCI    Advantages      • Reduced bleeding risk      •...
Radial Approaches         Issues• What are the advantages• Does this approach deliver?• What are the issues in delivering ...
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Transradial Access                 Site of Bleeding Complications                                                         ...
Transradial Access      Association Between Vascular Access Site                for PCI and Outcomes                      ...
Transradial Access      Association Between Vascular Access Site                for PCI and Outcomes                      ...
M.O.R.T.A.L. Study• British Columbia Cardiac Registry study• 38,872 procedures in 32,822 patients undergoing PCI• Purpose:...
M.O.R.T.A.L. Study                     Whole        Radial     Femoral                              Non-                  ...
M.O.R.T.A.L. Study                                Unadjusted Outcome                        Transfusion Status            ...
M.O.R.T.A.L. Study         ConclusionsIn a registry of all comers to PCI,transradial access was associatedwith a halving o...
Radial Intervention• RCT of 1005 patients undergoing PCI with bolus abciximab and uncomplicated transradial PCI• Randomiza...
Radial Intervention                                                                     Conclusion – Our data             ...
Outpatient Discharge Candidates        A Conservative Approach     Clinical       Anatomic + Procedural• Stable AP        ...
Radial Approaches     Benefits         Disadvantages• Improved patient    • Catheter size safety                      • He...
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TransRadial PCI: Advantages, Disadvantages, and Uptake in the U.S. and Abroad. TransRadial Education & Training & Therapy (TREATT) Thinktank.

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  1. 1. TransRadial PCI: Advantages, Disadvantages, and Uptake in the U.S. and Abroad TransRadial Education & Training & Therapy (TREATT) Thinktank Duke FDA Meeting Silver Spring, MD June 2010 David R. Holmes, MD Mayo Clinic Rochester, MN
  2. 2. Presenter Disclosure InformationDavid R. Holmes, Jr., M.D.“TransRadial PCI: Advantages, Disadvantages, and Uptake in the U.S. and Abroad”The following relationships exist related to this presentation:None
  3. 3. Radial Approaches Issues• What are the advantages• Does this approach deliver?• What are the issues in delivering it?• What is arteria subclavia dextra lusiria?
  4. 4. Transfemoral Approach• Dominant strategy since Dr Melvin Judkins• Large vessels• Preformed catheters• Avoided cutdowns (Brachial artery Sones)• Could tolerate larger catheter size• Could be repeated• Percutaneous• Anatomy straightforward
  5. 5. Transfemoral Approach• Entry site critical• Landmarks sometimes very problematic• The Red Sea• Space for unrecognized blood collections• Hemostasis• Peripheral arterial disease
  6. 6. Advantage and Disadvantages of Transradial Approach to PCI Advantages • Reduced bleeding risk • Reduced length of stay and costs • Early ambulation • Improved patient comfort • Obviates discontinuation of oral anticoagulant therapy • Same-day discharge possible Disadvantages • Learning curve • Not routinely taught in fellowship programs • Limits guide catheter size • Possible greater radiation exposure to operator • Long-term consequences to radial artery (eg, for re-access or for use as bypass graft) unknownRao SV et al: J Am Coll Cardiol 55:2187, 2010 3047869-6
  7. 7. Normal Radial Artery AnatomyHeart 95:410, 2009
  8. 8. Radial Approaches• Improved patient safety• Patient comfort – preference• Simplified post-procedural care• Decreased length of stay
  9. 9. Radial vs Femoral AccessSystematic Review and Meta Analysis• 23 randomized trials with 7,020 patients undergoing angiography or PCI• Endpoints: • Major bleeding • Death • MI • Procedural or fluoro time Jolly SS et al, Am Heart J 157:132-40, 2009
  10. 10. Radial vs Femoral Access Systematic Review and Meta AnalysisEndpoints (%) Radial Femoral OR PMajor bleeding 0.05 2.3 0.27 <0.001Death 1.2 1.8 0.74 0.29D, MI, Stroke, PCI 2.5 3.8 0.71 0.06Unable to cross lesions 4.7 3.4 1.29 0.21 Jolly SS et al, Am Heart J 157:132-40, 2009
  11. 11. Radial vs Femoral AccessSystematic Review and Meta Analysis Conclusions: Radial access reduced major bleeding and there was a corresponding trend for reduction in ischemic events compared to femoral access. Large randomized trials are needed to confirm the benefit of radial access on death an ischemic events. Jolly SS et al, Am Heart J 157:132-40, 2009
  12. 12. 3050029-12
  13. 13. Radial Approaches Issues• Physical set up – arm board• Radial anomalies• Learning curve• LIMA• Radiation exposure
  14. 14. Transradial approach• How do you introduce it?• Ergonomics and radiation exposure• Ergonomics and Left-Right• Prior CABG• Hemodynamic support• What is arteria subclavia dextra lusiria?
  15. 15. Radial Artery Anomalies • 1,540 consecutive patients undergoing first transradial procedure – angio + PCI • Retrograde radial angiography performedLo TS: Heart 95:410, 2009
  16. 16. Radial Artery Anomalies Clinical characteristics Mean age (yr) 63.6 M/F 70.6/29.4 PVD 8.8% Sheath size 5F 50.6 6F 48.0 7F 1.4 RA 93%Lo TS: Heart 95:410, 2009
  17. 17. Radial Artery Anomalies 1,540 patients 13.8% anomalies (212 patients) Full radial loop 16.5 Extreme tortuosity High-bifurcating 14.1 radial origin 50.9 Misc 18.3Lo TS: Heart 95:410, 2009
  18. 18. Complex Large Radial Artery LoopsHeart 95:410, 2009
  19. 19. Radial Artery Loop “Crossing” StraighteningHeart 95:410, 2009
  20. 20. High-Bifurcating Radial Artery that Rejoins the Brachial Artery at the Middle Third of the HumerusHeart 95:410, 2009
  21. 21. Extreme Radial Artery TortuosityHeart 95:410, 2009
  22. 22. Radial Artery Anatomy and Procedural Outcome 100 Normal radial anatomy (n=1,321) Radial anomaly (n=212) 80 P<0.001 60 P=NS 40 P=0.02 20 P<0.001 0 Mean age Women Mean Procedural (%) procedure failure (%)Heart 95:410, 2009 time (min)
  23. 23. Types of Radial Anomaly and Their Rates of Procedural Failure 120 Success 100 Failure 80 60 40 20 0 High Radial Tortuosity Others bifurcation loopHeart 95:410, 2009
  24. 24. High-Bifurcating Radial Artery Anastomosis Sites and Diameters Anastomosis Sites Diameters 50 40 30% 20 10 0 Axillary Upper Mid Lower <2.0 2.0-<2.5 2.5-3.0 >3.0 Humerus mmHeart 95:410, 2009
  25. 25. Radial Artery Anomalies Procedural failure 14.2 vs 0.9% P<0.001 anomaly vs not High-radial bifurcation 4.6% Radial loop 37.1% Radial tortuosity 23.3% Misc 12.9%Lo TS: Heart 95:410, 2009
  26. 26. Advantage and Disadvantages of Transradial Approach to PCI Advantages • Reduced bleeding risk • Reduced length of stay and costs • Early ambulation • Improved patient comfort • Obviates discontinuation of oral anticoagulant therapy • Same-day discharge possible Disadvantages • Learning curve • Not routinely taught in fellowship programs • Limits guide catheter size • Possible greater radiation exposure to operator • Long-term consequences to radial artery (eg, for re-access or for use as bypass graft) unknownRao SV et al: J Am Coll Cardiol 55:2187, 2010 3047869-31
  27. 27. Radial Approaches Issues• What are the advantages• Does this approach deliver?• What are the issues in delivering it?• What is arteria subclavia dextra lusiria?
  28. 28. 3047869-34
  29. 29. Transradial Access Site of Bleeding Complications CVA 100 2.9 GI RP 12.5 80 5.9 Hematoma 6.3 60 0.8 % 40 73.4 59 20 0 TIMI major TIMI minorRao SV et al: J Am Coll Cardiol 55:2187, 2010 3047869-36
  30. 30. Transradial Access Association Between Vascular Access Site for PCI and Outcomes 1.31 (0.87-1.96) (0.87- Procedure failureAccess site crossover 0.74 (0.42-1.30) (0.42- 3.82 (2.83-5.15) (2.83- Death 0.71 (0.49-1.01) (0.49- Death, stroke, or MI 0.27 (0.16-0.45) (0.16- Major bleeding Transradial better 1.0 Transfemoral betterRao SV et al: J Am Coll Cardiol 55:2187, 2010 3047869-37
  31. 31. Transradial Access Association Between Vascular Access Site for PCI and Outcomes 1.31 (0.87-1.96) (0.87- Procedure failureAccess site crossover 0.74 (0.42-1.30) (0.42- 3.82 (2.83-5.15) (2.83- Death 0.71 (0.49-1.01) (0.49- Death, stroke, or MI 0.27 (0.16-0.45) (0.16- Major bleeding Transradial better 1.0 Transfemoral betterRao SV et al: J Am Coll Cardiol 55:2187, 2010 3047869-38
  32. 32. M.O.R.T.A.L. Study• British Columbia Cardiac Registry study• 38,872 procedures in 32,822 patients undergoing PCI• Purpose: evaluate the association of arterial access site (radial or femoral) with transfusion and mortality Chase AJ et al, Heart 94:1019-1025, 2008
  33. 33. M.O.R.T.A.L. Study Whole Radial Femoral Non- Non-Raw outcomes sample cases cases Transfused transfusedwhole cohort (n=38,872) (n=7,972) (n=30,900) P (n=967) (n=37,905) P No. % No. % No. % No. % No. %Received 967 2.5 108 1.4 859 2.8 <0.01 967 100 <0.01transfusion30-day mortality30- 598 1.5 78 1.0 520 1.7 <0.01 122 12.6 476 1.3 <0.011-yr mortality 1,437 3.7 224 2.8 1,213 3.9 <0.01 221 22.9 1,216 3.2 <0.01Chase AJ et al: Heart 94:1019, 2008 3047177-40
  34. 34. M.O.R.T.A.L. Study Unadjusted Outcome Transfusion Status Radial vs Femoral 0.25 0.05 0.20 0.04 Femoral Transfused Mortality Mortality 0.15 0.03 0.10 0.02 Radial 0.05 Not transfused 0.01 0.00 0.00 0 100 200 300 400 0 100 200 300 400 Days DaysChase AJ et al: Heart 94:1019, 2008 3047177-41
  35. 35. M.O.R.T.A.L. Study ConclusionsIn a registry of all comers to PCI,transradial access was associatedwith a halving of the transfusionrate and a reduction in 30-day and1-year mortality. Chase AJ et al, Heart 94:1019-1025, 2008
  36. 36. Radial Intervention• RCT of 1005 patients undergoing PCI with bolus abciximab and uncomplicated transradial PCI• Randomization to: • Same day home discharge no infusion • Standard 12-hour infusion• Primary endpoint: • 30-day D • MI • Urgent revasc. • Major bleeding • Access site complications Bertrand OF et al, Circ 114:2636-43, 2006
  37. 37. Radial Intervention Conclusion – Our data suggest that same-day 1.0 home discharge afterProportion of patients uncomplicated transradial 0.8 coronary stenting and without event bolus only of abciximab is 0.6 not clinically inferior, in a wide spectrum of patients, 0.4 Same-day home discharge Same- to the standard overnight and single bolus hospitalization and a bolus 0.2 Overnight hospitalization followed by a 12-hour and bolus + infusion infusion. This novel 0.0 approach offers a safe 0 5 10 15 20 25 30 strategy for same-day Days to event home discharge after uncomplicated coronary intervention.Bertrand OF et al: Circ 114:2636, 2006 3047025-44
  38. 38. Outpatient Discharge Candidates A Conservative Approach Clinical Anatomic + Procedural• Stable AP • SVD• Asymptomatic + • 1 lesion in MVD ischemia • Single stent• Normal EF • Uncomplicated• Pre-loaded with procedure thienopyridine SCAI Expert Consensus Document
  39. 39. Radial Approaches Benefits Disadvantages• Improved patient • Catheter size safety • Hemodynamic• Patient comfort – support preference • Operator radiation• Simplified post procedure care • Access to LIMA• Decreased LOS • Training

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