The Femoral Arterial Access with Ultrasound Trial FAUST A prospective randomized controlled trial of

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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.
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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

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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 200851690-697
• Resnic FS et al Am J Cardiol 200799766 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
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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

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Site-Rite 5, Bard Access, Inc. 18g needle guide
9001C0212
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The goal
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FAUST Trial Design

• Prospective randomized controlled trial
• 4 hospitals, 34 operators
• Training / instruction
• US gelatin phantom and patients, 3 supervised
  procedures
• Fluoroscopy target center of femoral head
• Manual palpation of landmarks
• Femoral angiograms
• 30 day followup

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Entry Criteria
Inclusion Criteria
Exclusion 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

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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 gt 30)
• PVD

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Secondary Endpoints
Procedural Outcomes
Access Complications

• 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

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Enrolled, Randomized N1015
Canceled procedure (3)
Change in approach (2)
Excluded after randomization N11
No trained operator (4)
STEMI
No Pulses
Ultrasound N503
Fluoroscopy N501
Needle guide N454
Freehand N28
Not real time N21
Crossover to US N5
No Femoral Angiogram N11
No Femoral Angiogram N4
Fluoroscopy Angios N490
Ultrasound Angios N499
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Patient Population
pNS for Creatinine, Platelet, INR, CFA diameter
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Procedural Characteristics
Angioseal used in 80-83 of closures
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CFA Cannulation Success
p 0.15
p 0.11
p 0.78
p lt0.01
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Procedural Outcomes
p lt 0.000001
p lt 0.000001
p 0.016
p lt 0.000001
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Attending Physicians
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Complications
Blinded hematoma assessments 8 F, 0 US, plt0.01
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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

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CFA Success by US Experience
p NS
Ultrasound Procedures
p 0.0761 for F vs US 15
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Summary

• US guidance was superior to fluoroscopic guidance
  in achieving CFA placement in patients with a
  high bifurcation, with a trend towards benefit in
  the overall population
• US guidance facilitates femoral access
• Reduced number of attempts
• Reduced venipunctures
• Reduced time to successful insertion.
• US guidance reduced the risk of access
  complications by 59.

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Potential Impact

• For every 50 patients who receive US guidance,
  1 complication could be avoided.
• US guidance is likely cost-saving
• UK NICE US guidance for central lines saves
  2000 for every 1000 procedures performed
• 850 in disposables to prevent one complication
  vs. cost of 1400/hematoma
• Low major complication rate 2/503 (0.4) may
  make US-guided femoral access an alternative to
  radial access