The Femoral Arterial Access With Ultrasound Trial (faust)

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 Ndrepep G et al JACC 2008;51:690-697 Resnic FS et al Am J Cardiol 2007;99:766 –770

4. Huggins CE. J Inv Card 2009; 21(3) 105-9 5. Jacobi JA. Proc (Bayl Univ) 2009; 22(1)7-8 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

• Age ≥ 18 years • Scheduled for cardiac or peripheral angiography from retrograde femoral approach

• Written informed consent

• Primary operator trained in fluoroscopic and

Exclusion Criteria

• Nonpalpable femoral pulses

• ST elevation MI or unstable non STEMI

• Creatinine ≥ 3.0 mg/dL, unless already on dialysis

• Prisoners • Pregnant women

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 1st pass success rate Total number of attempts Accidental venipuncture Time to sheath insertion

Access Complications

• Hematoma ≥ 5 cm • Pseudoaneurysm • Retroperitoneal • • • • •

hemorrhage Arterial dissection Thrombosis Hgb ⇓≥3g/dL w/ access source Hgb ⇓≥4g/dL w/o overt source Non-CABG access bleeding requiring transfusion

Enrolled, Randomized N=1015 Excluded after randomization N=11

Fluoroscopy N=501

Ultrasound N=503

Crossover to US N=5

Needle guide N=454

Freehand N=28

No Femoral Angiogram N=11

Fluoroscopy Angios N=490

Canceled procedure (3) Change in approach (2) No trained operator (4) STEMI No Pulses

Not real time N=21

No Femoral Angiogram N=4

Ultrasound Angios N=499

Patient Population Fluoroscopy

Ultrasound

N=501

N=503

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

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

45 (9.2)

45 (9.0)

0.92

Characteristic Age, years

Body mass index (BMI)

Ipsilateral PVD (50% stenosis by angio)

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

P-value

Procedural Characteristics Fluoroscopy

Ultrasound

N=501

N=503

Coronary Angiogram

460 (91.8)

451 (89.7)

0.24

Peripheral Angiogram

41 (8.2)

52 (10.3)

0.24

161 (32.1)

155 (30.8)

0.65

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

Characteristic

Intervention Right Heart Cath

* Angioseal used in 80-83% of closures

P-value

CFA Cannulation Success p = 0.15

High stick CFA Low

Fluoroscop y 24 (4.9)

p = 0.11

Ultrasound

P-value

33 (6.6)

0.25

408 (83.3)

431 (86.4)

0.15

58 (11.8)

35 (7.0)

<0.01

p = 0.78

p <0.01

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%

1.3

2

40% 30% 20%

1

10%

0

0%

Fluoroscopy

Ultrasound

Fluoroscopy

Risk of Venipuncture 20%

15.8%

213

p < 0.000001

2.4%

5% 0%

p = 0.016 185

15% 10%

Ultrasound

Time to Sheath Insertion 300

Seconds

Attempts

4

200

100

0

Fluoroscopy

Ultrasound

Fluoroscopy

Ultrasound

Attending Physicians

Fluoroscopy

Ultrasound

N=31

N=35

2.8 ± 3.2

1.5 ± 1.5

0.040

17 (54.8)

29 (82.9)

0.013

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

Characteristic Number of attempts First pass success (%) Venipuncture (%)

P-value

Complications

Fluoroscopy

Ultrasound

N=501

N=503

11 (2.2%)

3 (0.6%)

0.034

Pseudoaneurysm

0

1

NS

Dissection

3

2

NS

Access bleeding, transfusion

2

1

NS

Hematoma, DVT

1

0

NS

Complication Hematoma >5 cm*

Any complication

17 (3.4%)

7 (1.4%)

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

P-value

0.041

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 87.6%

88% 87%

86.4%

85% 84%

83.3%

83.3%

83%

82.4%

82% 81%

+ 15

11 -1 5

710

46

ro sc op

y

80%

Fl uo

Percent

86%

Ultrasound Procedures

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%.