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Seto A - AIMRADIAL 2013 - RAUST trial
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  • 1. The Radial Artery access with Ultrasound Trial (RAUST) Arnold Seto, MD, MPA Jonathan S. Roberts MD, Mazen Abu-Fadel MD Zoran Lasic MD AIM-RADIAL Late-Breaking Clinical Trial September 26, 2013 Disclosures: None
  • 2. How hard is it to hit the radial artery? Femoral Artery ID 7 mm 2mm Radial Artery ID 2.6 mm 2mm 2mm Area 38 mm2 Area 5.3mm2 13% of transradial PCI failures are due to radial access failure. Deghani JACC Interv 2009 “Normal” two point discrimination is 2-4 mm at the fingertips. DeJong's neurologic examination
  • 3. How hard is it to hit the radial artery? Radial Artery ID 2.6 mm
  • 4. Ultrasound for Arterial Access
  • 5. FAUST: Procedural Outcomes First Pass Success Rate Number of Attempts 100% 5 p < 0.000001 90% p < 0.000001 82.7% 80% 3 70% 60% 3 46.4% 50% 2 1.3 40% 30% 1 20% 10% 0 0% Fluoroscopy Ultrasound Fluoroscopy Risk of Venipuncture 20% 300 15.8% 10% 2.4% 5% 0% p = 0.016 213 p < 0.000001 15% Ultrasound Time to Sheath Insertion 185 Seconds Attempts 4 200 100 0 Fluoroscopy Ultrasound Fluoroscopy Seto, JACC Cardiovasc Interv. 2010 Jul;3(7):751-8 Ultrasound
  • 6. Radial Access US Tips: • Keep probe near/over needle • Mark the center of the probe and line up artery with centerline • Short jabs on the skin or tissue to identify needle tip • Compress the skin to close the veins
  • 7. Longitudinal approach Adashi, J Clin Monit Comput 2013 epub
  • 8. Radial Artery Sizing
  • 9. Radial Access Radial tortuosity Ulnar tortuosity Yan ZX et al, Circ J 2010, 74:686-692 Radial stenosis
  • 10. Radial Artery Access Metaanalysis of First Pass Success Shiloh, AL et al, Chest 2011 139(3):524-9
  • 11. RAUST Study • Inclusion Criteria  Adults with planned radial catheterization  Functional ultrasound equipment and trained operator • Training: > 15 ultrasound radial procedures and > 100 radial cath • Attending physicians (13) and advanced interventional fellows (3) • Exclusion Criteria  Abnormal Barbeau’s (Class D) or Allen’s (>10sec) test  Emergency procedure (STEMI, shock)  ESRD on dialysis  Prior ipsilateral radial puncture within 1 week
  • 12. RAUST Study Primary Endpoints • First-pass success rate • Number of attempts to access  Forward motions separated by withdrawal of needle  Short “wiggle” to visualize path of needle on skin/tissue above plane of artery allowed  Announced by operator / confirmed by observer/tech • Time to access  From first application of US or needle for puncture to successful sheath insertion
  • 13. RAUST Study Secondary endpoints • Difficult access procedures 1. ≥ 5 minutes 2. ≥ 5 attempts • Crossover to ultrasound guidance • Crossover to another access site • Wrist pain (VAS 0-10) 1-4 hours after procedure • Radial spasm • Vascular complications  Hematoma >2cm, clinically evident RAO
  • 14. RAUST Study Procedural details • • • • • • 5F or 6F hydrophillic sheaths Single wall or double wall technique Patent hemostasis Lidocaine IA Heparin 2000-5000 units, or bivalirudin Verapamil 2.5 mg or NTG 100 mcg IA
  • 15. RAUST Study Design 698 patients with nonemergent radial angiography enrolled and randomized between December 2011 and March 2013 DESIGN: Prospective, multicenter randomized study OBJECTIVE: To evaluate the accuracy of ultrasound vs. palpation guidance for radial access. SITE LEAD INVESTIGATORS: Arnold Seto, Jonathan Roberts, Mazen Abu-Fadel, Zoran Lasic Palpation (n = 351) Procedural / Clinical outcomes 114 Censored* SITES: Jamaica / Lenox Hill Hospital (357) Long Beach VA / UC-Irvine (193) Miami Baptist (98) Oklahoma VA (50) Ultrasound (n=347) Palpation #attempts (n = 237) 111 Censored* Ultrasound #attempts (n=236) * First 225 patients from Jamaica Hospital censored due to first-pass success (96.5% P and 97.3% US) counted by # punctures
  • 16. Patient Population Palpation Ultrasound N=351 N=347 62.3 61.5 0.80 Male 262 (75%) 254 (73%) 0.66 Outpatient 141 (40%) 139 (40%) 0.98 30.2 30.4 0.64 Obesity (BMI >30) 153 (44%) 149 (43%) 0.86 Hypertension 305 (87%) 292 (84%) 0.30 Hypercholesterolemia 265 (75%) 254 (73%) 0.49 Diabetes Mellitus 151 (43%) 149 (43%) 0.98 Tobacco 107 (30%) 128 (37%) 0.07 16 (5%) 14 (4%) 0.73 54 / 149 (36%) 56 / 149 (38%) 0.81 Characteristic Age, years Body mass index (BMI) PVD Barbeau’s Class B or C P-value
  • 17. Procedural Characteristics Palpation Ultrasound N=351 N=347 Intervention 63 (18%) 73 (21%) 0.30 5F Sheath 193 (55%) 185 (53%) 0.66 Single wall technique 306 (87%) 295 (85%) 0.41 Right radial access 323 (92%) 328 (95%) 0.19 Verapamil (≥2.5mg) 340 (97%) 342 (99%) 0.20 Nitroglycerin (≥100mcg) 271 (77%) 278 (80%) 0.35 Lidocaine IA (5mg) 167 (48%) 170 (49%) 0.71 TR band Closure 225 (64%) 229 (66%) 0.60 D-stat band 114 (33%) 111 (32%) 0.89 Heparin 322 (92%) 321 (92%) 0.71 Heparin dose 3487 U 3700 U 0.16 GPIIb/IIIa 13 (4%) 14 (4%) 0.82 Bivalirudin 51 (15%) 50 (14%) 0.96 P2Y12 Inhibitor 193 (55%) 200 (58%) 0.48 Characteristic P-value
  • 18. Number of Attempts 4 p<0.0001 3.05 Attempts 3 1.65 2 1 0 N = 237 Palpation N = 236 Ultrasound
  • 19. Time to access 150 P=0.006 108 120 Seconds 88 90 60 30 0 N = 351 Palpation N = 347 Ultrasound
  • 20. Difficult Access ≥ 5 attempts ≥ 5 minutes 18.6% P<0.001 P=0.07 Percent 20 6.8% 10 3.7% 2.4% 0 237 236 Palpation Ultrasound 351 347 Palpation Ultrasound
  • 21. Clinical Outcomes Palpation Ultrasound N=351 N=347 12 (3%) 15 (4.3%) 0.56 0.71 0.69 0.85 4 (1.1%) 5 (1.4%) 0.75 10 (8 successful) N.A. N.A. Crossover to other site after successful sheath insertion 5 2 0.45 Crossover to other site before sheath insertion / failed access 7 3 0.34 Characteristic Spasm Pain score (0-10) Bleeding Crossover to ultrasound rescue attempts after >5 minutes P-value
  • 22. Radial Artery access with Ultrasound Trial Arnold Seto, MD MPA Summary Conclusions 1. Routine ultrasound guidance increases accuracy and reduces time for transradial access 2. Ultrasound guidance reduces the incidence of difficult access procedures, and is a useful rescue technique for palpation guided access 3. Ultrasound guidance does not reduce radial artery spasm, vascular complications, or patient pain.
  • 23. Results by Site