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Ruzsa Z - AIMRADIAL 2014 Endovascular - Carotid artery stenting

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A randomised comparison of transradial and transfemoral approach for carotid artery stenting: RADCAR study (RADial access for CARotid artery stenting)

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Ruzsa Z - AIMRADIAL 2014 Endovascular - Carotid artery stenting

  1. 1. A randomised comparison of transradial and transfemoral approach for carotid artery stenting: RADCAR study (RADial access for CARotid artery stenting)". Cardiology Center, Semmelweis University, Budapest, Hungary Bács-Kiskun County Hospital, Kecskemét, Hungary Augusta Hospital, Düsseldorf, Germany Zoltán Ruzsa, Balázs Nemes, Eszter Édes et al. AimRadial 2014 Chicago
  2. 2. Radial access for coronary angiography 2014 Summary: 84,2% ! 2247 2111 3020 4319 2332 3231 1990 2006 1498 1480 3336 4663 1677 1481 2825 1838 1952 2681 1913 1466 1799 1884 1855 2011 1456 1786 3933 1251 1381 773 1560 1668 1250 1377 1696 1490 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 6000 5000 4000 3000 2000 1000 0 All coronary angiographies Transradial coronary angiography
  3. 3. Transradial penetration in Hungary 26.9 44.0 53.4 76.6 84.2 90 80 70 60 50 40 30 20 10 0 2007 2008 2009 2010 2014 Radial access (%)
  4. 4. Background Severe access 1 Cannulation problems 2,3 1. Yoo BS. Catheter Cardiovasc Interv. 2002 Jun;56(2):243-5. 2. Gan HW. Catheter Cardiovasc Interv. 2010 Mar 1;75(4):540-3. 3. Shaw JA. Catheter Cardiovasc Interv. 2003 Dec;60(4):566-9.
  5. 5. Background (Transradial CAS) Publication year Study Patient No Success (%) Cross over (%) Asympt RAO (n, %) Major vasc complication MACC E Pinter et al. 1 2007 Pilot 20 90 10 5 0 0 Folmar J et al. 2 2007 Pilot 42 83 ? 0 0 2.3 Patel et al. 3 2010 Pilot 20 80 ? 0 0 5 Bakoyianni s C et al. 4 2010 Pilot 9 100 0 0 0 0 Mendiz Oa et al 5 2011 Pilot 79 98.8 ? 0 0 2 Ruzsa et al. 6 2012 Pilot 68 97.1 2.85 2.94 1.4 1.4 Etxegoien N et al 7 2013 Pilot 382 91 ? 6 0 0.6 1. Pinter et al. J Vasc Surg. 2007 Jun;45(6):1136-41. 2. Folmar J et al. Catheter Cardiovasc Interv. 2007 Feb 15;69(3):355-61. 3. Patel et al. Catheter Cardiovasc Interv. 2010 Feb 1;75(2):268-75. 4. Bakoyiannis C et al. Int Angiol. 2010 Feb;29(1):41-6. 5. Mendiz OA. Vasc Endovascular Surg. 2011 Aug;45(6):499-503. 6. Ruzsa et al. Cardiologia Hungarica. 2012; 42 : 6–X 7. Etxegoien N. Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1081-7.
  6. 6. Methods Study population. - The clinical and angiographic outcomes of 260 consecutive patients with high risk for carotid endarterectomy (9) treated by CAS with cerebral protection were evaluated in a prospective randomized multicenter study between 2010 and 2012. - Patients were randomized to TR (n =130) or TF (n =130) groups. Endpoints The following parameters were applied to evaluate the potential advantages of TR access: - Primary endpoint: MACCE, rate of major and minor access site complications. - Secondary endpoints: angiographic outcome of the CAS, and consumption of the angioplasty equipment, fluoroscopy time and X Ray dose, procedural time,cross over to another puncture site and hospitalisation days. Inclusion and exclusion criteria. - Inclusion criteria were: (1) Symptomatic (history of stroke or transient ischemic attack within 6 months) internal carotid artery stenosis (>70%) determided by magnetic resonance imaging or computer tomography and (2) critical asymptomatic (80%) ICA stenosis. - Exclusion criteria were: (1) history of acute or recent stroke (<2 months), myocardial infarction, and surgery or trauma within the preceeding 2 months, (2) unconsiousness or unwillingness to undergo the procedure, (3) known subclavian or brachiocephalic artery stenosis, (4) known iliac or common femoral stenosis, (5) contraindications of the transradial access (Negative Allen test, non-palpable radial artery).
  7. 7. 265 surgically high risk patients referred CAS Inclusion criteria Exclusion criteria 1. Asymptomatic critical ICA stenosis (>80%) 1. History of stroke, AMI and surgery within 2 months 2. Symptomatic significant ICA stenosis (>70%) 2. Unconsciousness and unwillingness to undergo the procedure 3. Known subclavian or anonym artery stenosis 4. Known iliac and common femoral artery stenosis 5. Contraindication of the radial artery puncture Randomized and enrolled 260 patients in the study 130 patients for transradial CAS 130 patients for transfemoral CAS 117 (90%) patients performed from the primary access 2 patients (1.5%) performed from secondary access 13 (10%) patients performed from secondary access 128 (98.5%) patients performed from the primary access Excluded 5 patients Crossover
  8. 8. Right sided lesion- Indirect cannulation Aortography with 15 ml contrast Pulling back and rotating the Simmons catheter 1. 2.
  9. 9. Right sided lesion Selective angiography in AP and LAO90 view
  10. 10. Right sided lesion
  11. 11. Right sided lesion
  12. 12. Left sided lesion- Indirect cannulation Aortography with 15 ml contrast Selective angiography in AP and LAO90 view 2. 1.
  13. 13. Left sided lesion
  14. 14. Left sided lesion
  15. 15. Bovine arch- direct cannulation Access: JR 7F Guiding: 7F JR3,5 Guidewire: Filter wire Stent: CarotisWallstent 7x30 mm Balloon: Sterling 4x20 and 6x20 mm
  16. 16. Aortic arch II-Loop technique Access: 7F Guiding: 7F XF40 Guidewire: Filter wire Stent: CarotisWallstent 7x30 mm Balloon: Sterling 5x20 mm
  17. 17. Loop technique
  18. 18. 19 Demographic and clinical data
  19. 19. Angiographic data 20
  20. 20. 21 Procedural data
  21. 21. Device consumption 22
  22. 22. Procedural data 23
  23. 23. Complications 24
  24. 24. Cross over cases 25
  25. 25. Impact of the learning curve (procedure time) Procedure time 5000 4000 3000 2000 1000 0 Year 1-2-3 PT (min) 26 Year 1 Year 2 Year 3 Time (mean, s) 2338 1752 * 1642 **
  26. 26. Impact of the learning curve (Fluoro Time) 27 Fluoro Time 2000 1500 1000 500 0 Year 1-2-3 FT (sec) Year 1 Year 2 Year 3 Time (mean, s) 767.2 646.3 * 587.7 **
  27. 27. Impact of the learning curve (Contrast) 28 Contrast consumption (ml) 250 200 150 100 50 0 Contrast (ml) Contrast (ml) Contrast (ml) Year 1-2-3 Contrast (ml) Year 1 Year 2 Year 3 Time (mean, s) 137.6 131.6 101.6 *
  28. 28. Impact of the learning curve (X Ray dose) 29 X Ray dose 800 600 400 200 0 Year 1-2-3 Dose (mGy) Year 1 Year 2 Year 3 X Ray (mean, mGy) 259 231 215 *
  29. 29. Dual center registry (2008-2014…) 30 Total Femoralis Total Radialis 300 250 200 150 100 50 0 350 2008 2009 2010 2011 2012 2013 Jun-14 300 200 100 Total Radialis Total Femoralis Contrast consumption (ml) 0 Year (1-5 year) Contrast (ml)
  30. 30. RADCAR II flow chart Design • DESIGN: Prospective, randomized, dual-arm, multi-center clinical evaluation of the transradial access for carotide artery stenting • OBJECTIVE: To evaluate the acute and long-term impact on cerebral microembolisation during transradial and transfemoral CAS • PRINCIPAL INVESTIGATOR Béla Merkely, MD, PhD, DsC Zoltán Ruzsa MD, PhD László Pintér MD 100 patients enrolled between January and December 2015 in 3 clinical sites in Europe, Excluded patients 100 with TR or TF CAS - DW MRI before and after intervention - Mini Mental test - TCD US follow-up at 12 months Clinical follow-up at 6 months Clinical follow-up and MMT at 12 months
  31. 31. Conclusion I. • Carotid artery stenting with cerebral protection devices can be safely and effectively performed using radial access with acceptable morbidity and high technical success. • Despite the promising early results the TF technique is superior to TR technique, but the TR technique allows earlier ambulation than the TF access • Learning curve plays an important factor in transradial CAS • Due to fast mobilisation the patient comfort is better
  32. 32. Thank You !!

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