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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
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
How hard is it to hit the radial artery?
Radial Artery
ID 2.6 mm
Ultrasound for Arterial Access
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
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
Longitudinal approach

Adashi, J Clin Monit Comput 2013 epub
Radial Artery Sizing
Radial Access

Radial tortuosity

Ulnar tortuosity

Yan ZX et al, Circ J 2010, 74:686-692

Radial stenosis
Radial Artery Access
Metaanalysis of First Pass Success

Shiloh, AL et al, Chest 2011 139(3):524-9
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
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
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
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
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
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
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
Number of Attempts
4

p<0.0001
3.05

Attempts

3

1.65

2

1

0

N = 237

Palpation

N = 236

Ultrasound
Time to access
150

P=0.006

108
120

Seconds

88
90

60

30

0
N = 351

Palpation

N = 347

Ultrasound
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
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
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.
Results by Site

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Seto A - AIMRADIAL 2013 - RAUST trial

  • 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
  • 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
  • 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
  • 19.
  • 21. 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
  • 22. 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
  • 23. 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.