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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
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
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.