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, MPAUniversity of California, Irvine

TCT Late Breaking Trial PresentationSeptember 25, 2009

Disclosures: Research materials grant, Bard Access, Inc.Disclosures: Research materials grant, Bard Access, Inc.

FAUST Investigators

•Lead investigatorLead investigator•Arnold SetoArnold Seto, MD, MPA, MD, MPA

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

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

•Clinical Trials IdentifierClinical Trials Identifier•NCT 00667381NCT 00667381

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

•Lead investigatorLead investigator•Arnold SetoArnold Seto, MD, MPA, MD, MPA

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

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

•Clinical Trials IdentifierClinical Trials Identifier•NCT 00667381NCT 00667381

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

Background

1.1. Tavris DR J Inv Cardiology 2004; 16(9):459-464Tavris DR J Inv Cardiology 2004; 16(9):459-4642.2. Ndrepep G et al JACC 2008;51:690-697Ndrepep G et al JACC 2008;51:690-6973.3. Resnic FS et al Am J Cardiol 2007;99:766 –770Resnic FS et al Am J Cardiol 2007;99:766 –770

4. Huggins CE. J Inv Card 2009; 21(3) 105-94. Huggins CE. J Inv Card 2009; 21(3) 105-95. Jacobi JA. Proc (Bayl Univ) 2009; 22(1)7-85. Jacobi JA. Proc (Bayl Univ) 2009; 22(1)7-86. Abu-Fadel MS. CCI 20096. Abu-Fadel MS. CCI 2009

• 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

Ultrasound guidance in Venous Access

1. BMJ. 2003 August 16; 327(7411): 361 1. BMJ. 2003 August 16; 327(7411): 361 2. AHRQ Publication 01-E058 July 18, 2001 2. AHRQ Publication 01-E058 July 18, 2001

• 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.

Site-Rite 6, Bard Access, Inc.Site-Rite 6, Bard Access, Inc.18g needle guide #9001C0212 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

• Age ≥ 18 years

• Scheduled for cardiac or peripheral angiography from retrograde femoral approach

• Written informed consent

• Primary operator trained in fluoroscopic and ultrasound technique

• Nonpalpable femoral pulses

• ST elevation MI or unstable non STEMI

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

• Prisoners

• Pregnant women

Inclusion CriteriaInclusion CriteriaInclusion CriteriaInclusion Criteria Exclusion CriteriaExclusion CriteriaExclusion CriteriaExclusion Criteria

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

• 1st pass success rate

• Total number of attempts

• Accidental venipuncture

• Time to sheath insertion

• 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

Procedural OutcomesProcedural OutcomesProcedural OutcomesProcedural Outcomes Access ComplicationsAccess ComplicationsAccess ComplicationsAccess Complications

Enrolled, Enrolled, RandomizedRandomized

N=1015N=1015

UltrasoundUltrasoundN=503N=503

FluoroscopyFluoroscopyN=501N=501

Excluded after randomizationExcluded after randomizationN=11N=11

Canceled procedure (3)Canceled procedure (3)

Change in approach (2)Change in approach (2)

STEMISTEMI

No PulsesNo Pulses

No trained operator No trained operator (4)(4)

Needle guideNeedle guideN=454N=454

FreehandFreehandN=28N=28

Not real timeNot real timeN=21N=21

No Femoral AngiogramNo Femoral AngiogramN=11N=11

No Femoral AngiogramNo Femoral AngiogramN=4N=4

Fluoroscopy AngiosFluoroscopy AngiosN=490N=490

Crossover to USCrossover to USN=5N=5

Ultrasound AngiosUltrasound AngiosN=499N=499

Patient Population

CharacteristicCharacteristic FluoroscopyFluoroscopyN=501N=501

UltrasoundUltrasoundN=503N=503

P-valueP-value

Age, yearsAge, years 64.264.2 63.563.5 0.330.33

MaleMale 366 (73.1)366 (73.1) 371 (73.8)371 (73.8) 0.800.80

WhiteWhite 329 (65.7)329 (65.7) 352 (70.0)352 (70.0) 0.140.14

OutpatientOutpatient 253 (50.5)253 (50.5) 265 (52.8)265 (52.8) 0.470.47

Body mass index Body mass index (BMI)(BMI) 29.429.4 30.130.1 0.110.11

Obesity (BMI >30)Obesity (BMI >30) 186 (37.1)186 (37.1) 210 (41.7)210 (41.7) 0.130.13

HypertensionHypertension 427 (85.2)427 (85.2) 426 (84.7)426 (84.7) 0.810.81

HypercholesterolemiaHypercholesterolemia 387 (77.2)387 (77.2) 405 (80.5)405 (80.5) 0.200.20

Diabetes MellitusDiabetes Mellitus 182 (36.3)182 (36.3) 203 (50.3)203 (50.3) 0.190.19

TobaccoTobacco 184 (36.7)184 (36.7) 226 (44.9)226 (44.9) 0.0080.008

Ipsilateral PVD Ipsilateral PVD

(50% stenosis by (50% stenosis by angio)angio)

45 (9.2)45 (9.2) 45 (9.0)45 (9.0) 0.920.92

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

Procedural Characteristics

CharacteristicCharacteristic FluoroscopyFluoroscopyN=501N=501

UltrasoundUltrasoundN=503N=503

P-valueP-value

Coronary AngiogramCoronary Angiogram 460 (91.8)460 (91.8) 451 (89.7)451 (89.7) 0.240.24

Peripheral AngiogramPeripheral Angiogram 41 (8.2)41 (8.2) 52 (10.3)52 (10.3) 0.240.24

InterventionIntervention 161 (32.1)161 (32.1) 155 (30.8)155 (30.8) 0.650.65

Right Heart CathRight Heart Cath 30 (6.0)30 (6.0) 44 (8.7)44 (8.7) 0.0940.094

Fellow InvolvedFellow Involved 470 (93.8)470 (93.8) 468 (93.0)468 (93.0) 0.620.62

HeparinHeparin 199 (39.7)199 (39.7) 211 (41.9)211 (41.9) 0.470.47

GPIIb/IIIaGPIIb/IIIa 38 (7.6)38 (7.6) 38 (7.6)38 (7.6) 0.990.99

BivalirudinBivalirudin 40 (8.0)40 (8.0) 38 (7.6)38 (7.6) 0.800.80

PlavixPlavix 251 (50.1)251 (50.1) 236 (46.9)236 (46.9) 0.310.31

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

* Angioseal used in 80-83% of closures* Angioseal used in 80-83% of closures

CFA Cannulation Success

FluoroscoFluoroscopypy

UltrasounUltrasoundd

P-valueP-value

High High stickstick 24 (4.9)24 (4.9) 33 (6.6)33 (6.6) 0.250.25

CFACFA 408 408 (83.3)(83.3)

431 431 (86.4)(86.4) 0.150.15

Low Low stickstick 58 (11.8)58 (11.8) 35 (7.0)35 (7.0) <0.01<0.01

p = 0.15p <0.01

p = 0.78p = 0.11

Number of Attempts

3

1.3

0

1

2

3

4

5

Fluoroscopy Ultrasound

Att

emp

ts

Procedural OutcomesFirst Pass Success Rate

46.4%

82.7%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Fluoroscopy Ultrasound

Risk of Venipuncture

2.4%

15.8%

0%

5%

10%

15%

20%

Fluoroscopy Ultrasound

Time to Sheath Insertion

213185

0

100

200

300

Fluoroscopy Ultrasound

Se

con

ds

p < 0.000001

p = 0.016

p < 0.000001p < 0.000001

Attending Physicians

CharacteristicCharacteristicFluoroscopyFluoroscopy

N=31N=31

UltrasounUltrasoundd

N=35N=35P-valueP-value

Number of Number of attemptsattempts 2.8 ±2.8 ± 3.23.2 1.5 ± 1.51.5 ± 1.5 0.0400.040

First pass success First pass success (%)(%) 17 (54.8)17 (54.8) 29 (82.9)29 (82.9) 0.0130.013

Venipuncture (%)Venipuncture (%) 9 (29.0)9 (29.0) 1 (2.9)1 (2.9) 0.00310.0031

Time to insertionTime to insertion 158 ± 108158 ± 108 161 ± 110161 ± 110 0.920.92

CFA CannulationCFA Cannulation 22 (71.0)22 (71.0) 26 (74.3)26 (74.3) 0.760.76

Complications

ComplicationComplicationFluoroscopyFluoroscopy

N=501N=501

UltrasounUltrasoundd

N=503N=503P-valueP-value

Hematoma >5 cm*Hematoma >5 cm* 11 (2.2%)11 (2.2%) 3 (0.6%)3 (0.6%) 0.0340.034

PseudoaneurysmPseudoaneurysm 00 11 NSNS

DissectionDissection 33 22 NSNS

Access bleeding, Access bleeding, transfusiontransfusion 22 11 NSNS

Hematoma, DVTHematoma, DVT 11 00 NSNS

Any Any complicationcomplication 17 (3.4%)17 (3.4%) 7 (1.4%)7 (1.4%) 0.0410.041

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

p= NSp= NS

UltrasoundUltrasound ProceduresProcedures

p= 0.0761 for F vs US 15+p= 0.0761 for F vs US 15+

83.3%

82.4%

83.3%

86.4%

87.6%

80%

81%

82%

83%

84%

85%

86%

87%

88%

89%

90%

Fluoro

scopy

4-6

7-10

11-1

515

+

Per

cen

t

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%.