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The Femoral Arterial Access

with Ultrasound Trial (FAUST)


A prospective randomized controlled trial of
ultrasound guidance versus standard fluoroscopic
technique in femoral access

Arnold Seto, MD, MPA


University of California, Irvine
TCT Late Breaking Trial Presentation
September 25, 2009

Disclosures: Research materials grant, Bard Access, Inc.


FAUST Investigators
•Lead investigator
•Arnold Seto, MD, MPA

•Co-Principal Investigators
•Mazen Abu-Fadel, MD, University of Oklahoma HSC
•Morton Kern, MD, UC-Irvine Medical Center and Long Beach VA

•Co-Investigators
•Jeffrey Sparling, Soni Zacharias, Timothy Daly, Thomas Hennebry
•Alexander Harrison, Will Suh, Jesus Vera, Pranav Patel, Rex Winters

•Clinical Trials Identifier


•NCT 00667381

•Supported by
•General Clinical Research Center at OUHSC, Chris Aston, PhD
•Long Beach Memorial Medical Foundation
Background

• Vascular access complications occur in


1.5%-4% of cardiac catheterizations. 1,2
• Bleeding is associated with increased
mortality and higher health care costs. 2,3
• Proper sheath placement in the common
femoral artery (CFA) is associated with a
lower risk of complications.
• Fluoroscopic guidance is widely
recommended, but three RCTs have
shown no difference in CFA placement
or complications.4-6
• Tavris DR J Inv Cardiology 2004; 16(9):459-464 4. Huggins CE. J Inv Card 2009; 21(3) 105-9
• Ndrepep G et al JACC 2008;51:690-697 5. Jacobi JA. Proc (Bayl Univ) 2009; 22(1)7-8
• Resnic FS et al Am J Cardiol 2007;99:766 –770 6. Abu-Fadel MS. CCI 2009
Ultrasound guidance in Venous Access

• Real-time Ultrasound (US) guidance reduces


complications and increases success rates in
central venous access. 1
• Named a “Top 11 Highly Proven” practice to
improve patient safety. 2
• US has not been adequately assessed in a
large trial of femoral arterial access.

1. BMJ. 2003 August 16; 327(7411): 361


2. AHRQ Publication 01-E058 July 18, 2001
Site-Rite 6, Bard Access, Inc.
18g needle guide #9001C0212
The goal
FAUST Trial Design

• Prospective randomized controlled trial


• 4 hospitals, 34 operators
• Training / instruction:
• Manual palpation of landmarks
• Fluoroscopy: target center of femoral head
• US: gelatin phantom and patients, 3 supervised procedures
• Femoral angiograms

• 30 day followup
Entry Criteria

Inclusion Criteria Exclusion Criteria


• Age ≥ 18 years • Nonpalpable
• Scheduled for femoral pulses
cardiac or • ST elevation MI or
peripheral unstable non STEMI
angiography from • Creatinine ≥ 3.0
retrograde femoral mg/dL, unless
approach already on dialysis
• Written informed • Prisoners
consent
• Pregnant women
• Primary operator
trained in
fluoroscopic and
Primary Endpoint

• Successful common
femoral artery (CFA)
cannulation
 above bifurcation and below
origin of inferior epigastric
artery

• Prespecified Subgroups:
 High CFA bifurcation (above
inferior border of femoral
head)
 Obese (BMI > 30)
 PVD
Secondary Endpoints

Procedural Outcomes Access Complications


• 1st pass success • Hematoma ≥ 5 cm
rate • Pseudoaneurysm
• Total number of • Retroperitoneal
attempts hemorrhage
• Accidental • Arterial dissection
venipuncture • Thrombosis
• Time to sheath • Hgb ⇓≥3g/dL w/
insertion access source
• Hgb ⇓≥4g/dL w/o
overt source
• Non-CABG access
bleeding requiring
transfusion
Enrolled,
Randomized
N=1015
Canceled procedure (3)
Change in approach (2)
Excluded after randomization
No trained operator (4)
N=11
STEMI
No Pulses

Fluoroscopy Ultrasound
N=501 N=503

Crossover to US Needle guide Freehand Not real time


N=5 N=454 N=28 N=21

No Femoral Angiogram No Femoral Angiogram


N=11 N=4

Fluoroscopy Angios Ultrasound Angios


N=490 N=499
Patient Population
Fluoroscopy Ultrasound
Characteristic P-value
N=501 N=503

Age, years 64.2 63.5 0.33

Male 366 (73.1) 371 (73.8) 0.80

White 329 (65.7) 352 (70.0) 0.14

Outpatient 253 (50.5) 265 (52.8) 0.47

Body mass index (BMI) 29.4 30.1 0.11

Obesity (BMI >30) 186 (37.1) 210 (41.7) 0.13

Hypertension 427 (85.2) 426 (84.7) 0.81

Hypercholesterolemia 387 (77.2) 405 (80.5) 0.20

Diabetes Mellitus 182 (36.3) 203 (50.3) 0.19

Tobacco 184 (36.7) 226 (44.9) 0.008


Ipsilateral PVD
45 (9.2) 45 (9.0) 0.92
(50% stenosis by angio)

p=NS for Creatinine, Platelet, INR, CFA diameter


Procedural Characteristics

Fluoroscopy Ultrasound
Characteristic P-value
N=501 N=503

Coronary Angiogram 460 (91.8) 451 (89.7) 0.24

Peripheral Angiogram 41 (8.2) 52 (10.3) 0.24

Intervention 161 (32.1) 155 (30.8) 0.65

Right Heart Cath 30 (6.0) 44 (8.7) 0.094

Fellow Involved 470 (93.8) 468 (93.0) 0.62

Heparin 199 (39.7) 211 (41.9) 0.47

GPIIb/IIIa 38 (7.6) 38 (7.6) 0.99

Bivalirudin 40 (8.0) 38 (7.6) 0.80

Plavix 251 (50.1) 236 (46.9) 0.31

Closure device used* 274 (55.2) 332 (66.4) <0.001

* Angioseal used in 80-83% of closures


CFA Cannulation Success

p = 0.15 p = 0.11 p = 0.78


p <0.01

Fluoroscop
Ultrasound P-value
y
High
24 (4.9) 33 (6.6) 0.25
stick
CFA 408 (83.3) 431 (86.4) 0.15
Low
58 (11.8) 35 (7.0) <0.01
Procedural Outcomes
First Pass Success Rate
Number of Attempts
100%
82.7%
5 90% p < 0.000001
p < 0.000001
80%
4
3 70%
Attempts

60% 46.4%
3
50%
40%
2 1.3
30%

1 20%
10%
0 0%

Fluoroscopy Ultrasound Fluoroscopy Ultrasound

Risk of Venipuncture Time to Sheath Insertion


300
15.8% p = 0.016
20%
213
p < 0.000001 185
15% Seconds
200

10%
100
2.4%
5%

0% 0

Fluoroscopy Ultrasound Fluoroscopy Ultrasound


Attending Physicians

Fluoroscopy Ultrasound
Characteristic P-value
N=31 N=35

Number of attempts 2.8 ± 3.2 1.5 ± 1.5 0.040


First pass success
17 (54.8) 29 (82.9) 0.013
(%)
Venipuncture (%) 9 (29.0) 1 (2.9) 0.0031
Time to insertion 158 ± 108 161 ± 110 0.92
CFA Cannulation 22 (71.0) 26 (74.3) 0.76
Complications

Fluoroscopy Ultrasound
Complication P-value
N=501 N=503

Hematoma >5 cm* 11 (2.2%) 3 (0.6%) 0.034


Pseudoaneurysm 0 1 NS
Dissection 3 2 NS
Access bleeding,
2 1 NS
transfusion
Hematoma, DVT 1 0 NS

Any complication 17 (3.4%) 7 (1.4%) 0.041

*Blinded hematoma assessments: 8 F, 0 US, p<0.01


Limitations

• Inability to blind operator from randomization


• Results specific for needle guide system
• Did not test combination of Fluoroscopy,
Ultrasound
• Limited training for ultrasound operators
CFA Success by US Experience
90%

89%
p= NS
88% 87.6%

87%
86.4%

86%
Percent

85%

84%
83.3% 83.3%
83%
82.4%

82%

81%

80%
10

+
6

5
y

4-

15
-1
op

7-

11
sc
ro

Ultrasound Procedures
uo
Fl

p= 0.0761 for F vs US 15+


Summary

• US guidance is not superior to fluoroscopic guidance


in achieving CFA placement, except in patients with a
high bifurcation.

• US guidance facilitates femoral access


 Reduced number of attempts
 Reduced venipunctures
 Reduced time to successful insertion.

• US guidance reduces the risk of access


complications by 59%.