Seoul Radial Artery Access 2009 1

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LENOX HILL HOSPITAL TRANSRADIAL COURSE, Radial Artery Access Improving Outcomes in PCI

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Seoul Radial Artery Access 2009 1

  1. 1. Howard A. Cohen, MD, FACC, FSCAI Director, Division of Cardiac Intervention Co-Director, Cardiac Catheterization Laboratories Lenox Hill Heart & Vascular Institute LENOX HILL HOSPITAL TRANSRADIAL COURSE New York, NY October 23-24, 2009
  2. 2. DISCLOSURE <ul><li>Vascular Solutions – Grant support </li></ul>
  3. 3. Why Do Transradial Access? <ul><li>Improve outcomes </li></ul><ul><ul><li>Improve procedural success? </li></ul></ul><ul><ul><ul><li>Short-term </li></ul></ul></ul><ul><ul><ul><li>Long-term </li></ul></ul></ul><ul><ul><li>Decrease complications? </li></ul></ul><ul><li>Decrease costs? </li></ul><ul><li>Improve patient satisfaction? </li></ul>
  4. 4. Why Do Transradial Access? <ul><li>Background </li></ul><ul><ul><li>Transradial access originally initiated because of bleeding associated with PCI/Stenting </li></ul></ul><ul><ul><li>Radial artery is superficial </li></ul></ul><ul><ul><li>Radial artery is easily compressible </li></ul></ul><ul><ul><li>No critical structures in proximity </li></ul></ul><ul><ul><li>Most patients have dual arterial supply to hand </li></ul></ul>
  5. 5. TRANSRADIAL PTCA <ul><li>The Access Trial </li></ul><ul><li>900 patients randomized to radial, brachial or femoral access 1993-1995 </li></ul><ul><li>6 F guiding catheters </li></ul><ul><li>Heparin 5000u </li></ul><ul><li>Stents 5.5% (Palmaz-Schatz) </li></ul><ul><li>Primary EP’s access and PTCA related </li></ul><ul><li>Secondary EP’s QCA, procedural and fluoro times, equipment consumption and LOS </li></ul><ul><li>Kiemeneij et al. J Am Coll Cardiol 1997:1269-75 </li></ul>
  6. 6. TRANSRADIAL PTCA <ul><li>The Access Trial </li></ul><ul><li>Kiemeneij et al. J Am Coll Cardiol 1997; 29:1269-75 </li></ul>Radial N=300 Brachial N=300 Femoral N=300 p value Successful access 93.0% 95.7% 99.7% 0.001 PTCA Success 91.7% 90.7% 90.7% ns Access Compl 0% 2.3% 2.0% 0.035 Time 40±24 39±25 38±24 ns
  7. 7. TRANSRADIAL CATHETERIZTION <ul><li>Stenting in ACS: A Comparison of Radial vs Femoral Access Sites </li></ul><ul><li>Mann et al. J Am Coll Cardiol 1998; 32:572-76 </li></ul>RADIAL n=68 FEMORAL n=77 p value 1° Success 65 (96%) 74 (96%) ns D/MI/CABG 0 0 ns Access site Comp 0 3 (4%) p<0.01
  8. 8. TRANSRADIAL CATHETERIZTION <ul><li>Stenting in ACS: A Comparison of Radial vs Femoral Access Sites </li></ul><ul><li>Mann et al. J Am Coll Cardiol 1998;323:572-76 </li></ul>RADIAL FEMORAL p Value Post op LOS 1.4 2.3 p<0.01 Hospital LOS 3.0 4.5 p<0.01 Total Charges 20,476 23,389 p<0.01
  9. 9. TRANSRADIAL APPROACH in AMI Prospective Consecutive PTCA in Two Centers <ul><li> Study Center A Study Center B </li></ul><ul><li> RA (n=180) FA-P (n=889) RA(n=87) FA-M(n=58) </li></ul><ul><li>Age 60  14 63  16 59  14 60  12 </li></ul><ul><li>Male 80% 76% 91% 84% </li></ul><ul><li>Primary 75.6% 85.8% 79.3% 75.9% </li></ul><ul><li>Rescue 24.4% 14.2% 20.7% 24.1% </li></ul><ul><li>Anterior 43.9% 47.6% 70.1% 60.3% </li></ul><ul><li>Louvard et al: Cath and CV Interventions 55:206-211, 2002 </li></ul>
  10. 10. TRANSRADIAL APPROACH in AMI Prospective Consecutive PTCA in Two Centers <ul><li>Study Center A Study Center B </li></ul><ul><li> RA (n=180) FA-P (n=889) RA(n=87) FA-M(n=58) </li></ul><ul><li>RA to FA(%) 2 4 </li></ul><ul><li>Access(%) 2 2 </li></ul><ul><li>Spasm (%) 0 2 </li></ul><ul><li>Success (%) 98 97 96 98 </li></ul><ul><li>Stent (%) 89 91 83 81 </li></ul><ul><li>Time 45  42 43  32 67  25 68±21 </li></ul><ul><li>Access NA NA 25  9 23  9 </li></ul><ul><li>FBI NA NA 50  14 50  18 </li></ul><ul><li>Louvard et al: Cath and CV Interventions 55:206-211, 2002 </li></ul>
  11. 11. TRANSRADIAL APPROACH in AMI Prospective Consecutive PTCA in Two Centers <ul><li>Study Center A Study Center B </li></ul><ul><li> RA (n=180) FA-P (n-889) p RA(n=87) FA-M(n=58) p </li></ul><ul><li>Local Comp 0 2 NS 0 10 <0.01 </li></ul><ul><li>v repair 0 0 NS 0 3 NS </li></ul><ul><li>M bleed 0 2 NS 0 7 <0.05 </li></ul><ul><li>Louvard et al: Cath and CV Interventions 55:206-211, 2002 </li></ul>
  12. 12. EFFECT of TRANSRADIAL ACCESS on QUALITY OF LIFE AND COST A RANDOMIZED COMPARISON <ul><li>Femoral Radial p Value </li></ul><ul><li>(n=99) (n=101) </li></ul><ul><li>Procedure Outcome </li></ul><ul><li>Success 98 99 ns </li></ul><ul><li>Crossover 1 2 ns </li></ul><ul><li>Sheath Insertion (min) 5.1  0.6 8  0.8 <0.01 </li></ul><ul><li>Cath time(min) 16.4  1 18.6  0.9 ns </li></ul><ul><li>Hemostasis time(min) 26.5  2.3 4.7  0.6 <0.001 </li></ul><ul><li>Total Procedure (min) 47.6  2.7 31.4  1.7 <0.001 </li></ul><ul><li>Hospital stay (hours) 10.4(8.3,22.7) 3.6(3.0,4.6) <0.001 </li></ul><ul><li>Complications ns </li></ul><ul><li>Cooper et al. Am Heart J 138:430-436,1999 </li></ul>
  13. 13. EFFECT of TRANSRADIAL ACCESS on QUALITY OF LIFE AND COST A RANDOMIZED COMPARISON <ul><li>Femoral Radial p Value </li></ul><ul><li>(n=99) (n=101) </li></ul><ul><li>Other Outcomes </li></ul><ul><li>Costs ($) 2229 2010 <0.001 </li></ul><ul><li>Patient preference ++++ <0.001 </li></ul><ul><li> Cooper et al. Am Heart J 138:430-436,1999 </li></ul>
  14. 14. RANDOMIZED COMPARISON OF TRANSRADIAL AND TRANFEMORAL APPROACHES IN OCTAGENARIANS Louvard et al Am J Cardiol 92:17L, 2003 RADIAL P VALUE FEMORAL Crossover 11.7 NS 9.5 Angio Duration(min) 18.1  10.8 NS 16.4  10.8 Xray Duration(min) 6.1  4.8 0.001 4.4  3.4 PCI Success (%) 96.8 NS 94.7 PCI Duration(min) 27.6  18.2 NS 33.3  23.2 Xray Duration(min) 9.9  8.3 NS 10.7  10.2 Primary EP (%) 1.4 0.08 5.9(58.5% FCD) Hematoma >3cm(%) 2.2 0.004 11.4
  15. 15. TRANSRADIAL CATHETERIZATION <ul><li>Learning Curve </li></ul><ul><li>Spaulding et al. Cathet Cardiovasc Diagn 39:365-70, 1996 </li></ul><80 PATIENTS >80 PATEINTS Access Failure 14% 2% Access Time 10.2±12.9 m ±2.8±2.5 Procedure Time 25.7±12.9 m 17.4±4,7
  16. 16. <ul><li>Meta-Analysis of transfemoral vs transradial access for coronary procedures </li></ul><ul><li>Twelve randomized trials 3224 patients </li></ul><ul><li>Failure, access complication, MACE </li></ul>Agostononi et al. J Am Coll Cardiol 2004;44:349-56
  17. 17. TRANRADIAL VS TRANSFEMORAL ACCESS Agostononi et al. J Am Coll Cardiol 2004;44:349-56
  18. 18. TRANRADIAL VS TRANSFEMORAL ACCESS Agostononi et al. J Am Coll Cardiol 2004;44:349-56 MACE
  19. 19. TRANRADIAL VS TRANSFEMORAL ACCESS Agostononi et al. J Am Coll Cardiol 2004;44:349-56 ENTRY SITE COMPLICATIONS
  20. 20. TRANRADIAL VS TRANSFEMORAL ACCESS Agostononi et al. J Am Coll Cardiol 2004;44:349-56 RISK OF PROCEDURAL FAILURE
  21. 21. TRANRADIAL VS TRANSFEMORAL ACCESS <ul><li>Conclusions </li></ul><ul><ul><li>TRA is as safe as TFA </li></ul></ul><ul><ul><li>TRA eliminates access site complications </li></ul></ul><ul><ul><li>Lower overall procedure success rate </li></ul></ul>Agostononi et al. J Am Coll Cardiol 2004;44:349-56
  22. 22. BLEEDING AND PCI OUTCOMES <ul><li>Access site hematoma requiring blood transfusion predicts mortality in patients undergoing PCI: Data from the NHLBI Dynamic Registry </li></ul><ul><li>6652 Patients between 1997 and 2002 </li></ul><ul><li>In hospital mortality among patients with HRT was 9 times higher than patients without HRT and by one year patients with HRT were 4.5 times more likely to die </li></ul>Yatskaar L et al. Catheter Cardiovasc Interv 2007;69:961-6
  23. 23. BLEEDING AND OUTCOMES WITH PCI IN ACS J Am Coll Cardiol 2007;49:1362-8
  24. 24. BLEEDING AND OUTCOMES WITH PCI IN ACS Manoukian, S. V. et al. J Am Coll Cardiol 2007;49:1362-1368 INDEPENDENT PREDICTORS OF MAJOR BLEEDING
  25. 25. BLEEDING AND OUTCOMES WITH PCI IN ACS Manoukian, S. V. et al. J Am Coll Cardiol 2007;49:1362-1368 INDEPENDENT PREDICTORS OF MORTALITY
  26. 26. Radial Artery Access Improving Outcomes and Decreasing Costs Manoukian, S. V. et al. J Am Coll Cardiol 2007;49:1362-1368 MORTALITY AND MAJOR BLEEDING
  27. 27. Radial Artery Access Improving Outcomes and Decreasing Costs Types of Major Bleeding by Treatment Group Manoukian, S. V. et al. J Am Coll Cardiol 2007;49:1362-1368
  28. 28. BLEEDING AND OUTCOMES WITH PCI IN ACS Nikolsky, E. et al. J Am Coll Cardiol Intv 2009;2:624-632
  29. 29. Nikolsky, E. et al. J Am Coll Cardiol Intv 2009;2:624-632 Kaplan-Meier Estimates of Adverse Events at 1 Year BLEEDING AND OUTCOMES WITH PCI IN ACS
  30. 30. PCI COMPLICATIONS AND GUIDE CATHETER SIZE BIGGER IS NOT BETTER <ul><li>Evaluation association between guide catheter size and complications of PCI </li></ul><ul><li>103,070 consecutive patients </li></ul><ul><li>6F (n=64,335), 7F(n=32,676), 8F(n=6,059) </li></ul><ul><li>Univariate and multivariate logistic regression modeling to calculate unadjusted and adjusted odds for complications </li></ul>Grossman, P. M. et al. J Am Coll Cardiol Intv 2009;2:636-644
  31. 31. . Grossman, P. M. et al. J Am Coll Cardiol Intv 2009;2:636-644 8F GUIDE USE
  32. 32. Grossman, P. M. et al. J Am Coll Cardiol Intv 2009;2:636-644 IN HOSPITAL OUTCOMES 8F VS 6F GUIDES
  33. 33. Grossman, P. M. et al. J Am Coll Cardiol Intv 2009;2:636-644 S STANDARDIZED MORTALITY RATE BASED ON GUIDE SIZE
  34. 34. Grossman, P. M. et al. J Am Coll Cardiol Intv 2009;2:636-644 TEMPORAL USE OF 6,7 AND 8F GUIDES
  35. 35. Radial Artery Access Improving Outcomes and Decreasing Costs “… hospital savings were due primarily to a reduction in major bleeding.”
  36. 36. Association of the Arterial Access Site at Angioplasty with Transfusion and Mortality: the MORTAL Study (Mortality Benefit of Reduced Transfusion After Percutaneous Coronary Intervention via the Arm or Leg) <ul><li>Objective – To determine the association of arterial access site (radial or femoral) with transfusion and mortality in unselected patients </li></ul><ul><li>Study Design: Retrospective, non-randomized analysis of three prospectively collated registries of 32,822 patients in British Columbia </li></ul><ul><li>The association between access site, transfusion and outcomes assessed by logistic regression, propensity score matching and probit regression </li></ul>Chase A J et al. Heart 2008;95:1019-1025
  37. 37. MORTAL STUDY Chase et al. Heart ;94:1019-1025,2008
  38. 38. MORTAL STUDY Chase et al. Heart ;94:1019-1025,2008 Predictors of 1-Year Mortality in the Mortal Study
  39. 39. MORTAL STUDY Chase et al. Heart ;94:1019-1025,2008
  40. 40. MORTAL STUDY 914 Matched Patients p=0.96 Chase et al. Heart ;94:1019-1025,2008 Trans No Trans ARR NNT RR 95% CI 30 Day Mortality 7.7% 2% 5.7 18 3.9 1.89-8.0 1 Year Mortality 19.3% 5.7% 12.5 7.4 3.38 2.22-5.14
  41. 42. Rao, S. V. et al. J Am Coll Cardiol Intv 2008;1:379-386 Proportion of PCI Cases Performed Via TRA
  42. 43. TRENDS IN TRANSRADIAL PCI Rao et al. J. Am. Coll. Cardiol. Intv :2008; 1:379-383
  43. 44. UNADJUSTED OUTCOMES Rao et al. J. Am. Coll. Cardiol. Intv :2008; 1:379-383
  44. 45. UNADJUSTED RATES OF BLEEDING & VASCULAR COMPLICATIONS IN KEY SUB-GROUPS Rao et al. J. Am. Coll. Cardiol. Intv :2008; 1:379-383
  45. 46. Effect of Age, Gender,and Indication on Association of r-PCI Success and Bleeding Complications Rao et al. J. Am. Coll. Cardiol. Intv :2008; 1:379-383
  46. 47. Unadjusted and Adjusted Association Between PCI and Primary Outcomes (f PCI as Reference) Rao et al. J. Am. Coll. Cardiol. Intv :2008; 1:379-383 Outcome Unadjusted Odds Ratio (95% CI) Adjusted Odds Ratio (95% CI) Procedural Success 1.09 (0.97-1.23) 0.92 (1.02-1.12) Any Bleeding Comp 0.38 (0.26-.0.54) 0.42 (0.31-0.56)
  47. 48. CONCLUSIONS <ul><li>Radial PCI….is infrequently used…but is associated with a rate of procedural success similar to the femoral approach with lower rates of bleeding and vascular complications </li></ul><ul><li>These findings were present even among patients at high risk for PCI-related complications such as elderly patients, women and patients with ACS. </li></ul><ul><li>These data, in the context of prior clinical trials, suggest that wider adoption of radial PCI in clinical practice may improve the safety of PCI </li></ul>Rao et al. J. Am. Coll. Cardiol. Intv :2008; 1:379-383
  48. 49. PREVAIL STUDY <ul><li>Prospective observational study involving nine centers and 1052 patients </li></ul><ul><li>All consecutive patients who underwent an invasive procedure </li></ul><ul><li>Arterial access site and technique employed was made by individual practitioner according to usual practice </li></ul><ul><li>Multivariate analysis adjusted with propensity score </li></ul>Pristipino et al. Heart :2009;95:476-82
  49. 50. PREVAIL STUDY Pristipino et al. Heart :2009;95:476-82 Overall (1052) Femoral (543) Radial (509) P Value Male gender 71% 66% 75% <0.002 Prior radial 9% 4% 14% <0.0001 Prior PCI 20% 17% 24% <0.01 Chronic SAP 35% 28% 42% <0.0001 ACS 31% 35% 28% <0.01 Sheath size F 5.9 6.1 5.7 <0.0001 Heparin IU 4950 4270 5650 <0.0001 GP II IIIa RA 12% 8% 15% <0.002
  50. 51. Major Improvement of PCI Outcomes with Radial Artery Access from the Prevail Study Pristipino et al. Heart :2009;95:476-82
  51. 52. Major Improvement of PCI Outcomes with Radial Artery Access from the Prevail Study Pristipino et al. Heart :2009;95:476-82 Stable ACS
  52. 53. Major Improvement of PCI Outcomes with Radial Artery Access from the Prevail Study Pristipino et al. Heart :2009;95:476-82 Adjusted Multivariate Analysis
  53. 54. PREVAIL STUDY <ul><li>86% Reduction in clinical and procedural adjusted risk of in-hospital death or infarction/reinfarction in patients undergoing PCI by the radial approach (based on intention-to-treat) </li></ul><ul><li>Confirmed by multivariate analysis and propensity adjustment </li></ul><ul><li>Highest baseline risk patients (ACS,STEMI) contributed mostly to the outcome benefit by the radial approach suggests that baseline bias is less relevant in this study </li></ul>
  54. 55. BLEEDING/TRANSFUSION AND ADVERSE OUTCOMES IN PCI <ul><li>Potential Mechanisms </li></ul><ul><ul><li>Hemodynamic compromise </li></ul></ul><ul><ul><li>Induction of hyperadrenergic state </li></ul></ul><ul><ul><li>Induction of inflammatory state </li></ul></ul><ul><ul><li>Cessation of anti-thrombotic/anti-platelet agents </li></ul></ul><ul><ul><li>Altered characteristics of older banked blood such as reduced O2 delivery, NO depletion, or stimulation of vasoconstriction </li></ul></ul>
  55. 56. TRANS RADIAL CATHETERIZATION <ul><li>Complications </li></ul><ul><ul><li>Radial artery occlusion 1-5% (heparin dose and hemodynamic monitoring) of no consequence </li></ul></ul><ul><ul><li>Severe hematoma - very rare </li></ul></ul><ul><ul><li>Compartment syndrome - very rare –unsuspected guidewire perforation </li></ul></ul><ul><ul><li>Hand ischemia (should not occur with normal Allen Test) </li></ul></ul>
  56. 57. Why Do Transradial Access? <ul><li>Improve outcomes - Yes </li></ul><ul><ul><li>Improve procedural success - Yes </li></ul></ul><ul><ul><ul><li>Short-term </li></ul></ul></ul><ul><ul><ul><li>Long-term </li></ul></ul></ul><ul><ul><li>Decrease complications – Yes </li></ul></ul><ul><ul><ul><li>Primarily access site bleeding </li></ul></ul></ul><ul><ul><ul><li>Decrease transfusion requirement </li></ul></ul></ul><ul><li>Decrease costs - Yes </li></ul><ul><li>Improve patient satisfaction - Yes </li></ul>Radial Artery Access Improving Outcomes in PCI
  57. 58. TRANSRADIAL ACCESS <ul><li>Dr. L. Yogi Berra </li></ul><ul><li>“ Just remember, it’s not over ‘til it’s over” </li></ul><ul><li>The PCI is not over with the successful delivery of the stent </li></ul><ul><li>The successful PCI is over when the patient leaves the hospital with a good angiographic result and no early or late complication </li></ul>
  58. 59. TRANSRADIAL ACCESS <ul><li>Just remember, “it’s not over until the fat lady (your patient) sings” </li></ul><ul><li>But is she singing your praises or the “blues” </li></ul><ul><li>The “black and blues” </li></ul><ul><li>Try radial access. Try it you’ll like it! Your patients will love it!!! </li></ul>
  59. 60. <ul><li>THANK YOU </li></ul>

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