The Femoral Arterial Access with Ultrasound Trial (FAUST) A prospective randomized controlled trial of ultrasound guidance versus standard fluoroscopic technique in femoral access - PowerPoint PPT Presentation

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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

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Title: The Femoral Arterial Access with Ultrasound Trial (FAUST) A prospective randomized controlled trial of ultrasound guidance versus standard fluoroscopic technique in femoral access


1
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.
2
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

3
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
  1. Tavris DR J Inv Cardiology 2004 16(9)459-464
  2. Ndrepep G et al JACC 200851690-697
  3. 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
4
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

5
Site-Rite 6, Bard Access, Inc. 18g needle guide
9001C0212
6
The goal
7
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

8
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

9
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

10
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

11
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
12
Patient Population
Characteristic Fluoroscopy N501 Ultrasound N503 P-value
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 gt30) 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 (50 stenosis by angio) 45 (9.2) 45 (9.0) 0.92
pNS for Creatinine, Platelet, INR, CFA diameter
13
Procedural Characteristics
Characteristic Fluoroscopy N501 Ultrasound N503 P-value
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) lt0.001
Angioseal used in 80-83 of closures
14
CFA Cannulation Success
p 0.15
p 0.11
p 0.78
p lt0.01
Fluoroscopy Ultrasound P-value
High stick 24 (4.9) 33 (6.6) 0.25
CFA 408 (83.3) 431 (86.4) 0.15
Low stick 58 (11.8) 35 (7.0) lt0.01
15
Procedural Outcomes
p lt 0.000001
p lt 0.000001
p 0.016
p lt 0.000001
16
Attending Physicians
Characteristic Fluoroscopy N31 Ultrasound N35 P-value
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
17
Complications
Complication Fluoroscopy N501 Fluoroscopy N501 Ultrasound N503 P-value
Hematoma gt5 cm 11 (2.2) 11 (2.2) 3 (0.6) 0.034
Pseudoaneurysm 0 0 1 NS
Dissection 3 3 2 NS
Access bleeding, transfusion 2 2 1 NS
Hematoma, DVT 1 1 0 NS

Any complication 17 (3.4) 7 (1.4) 7 (1.4) 0.041
Blinded hematoma assessments 8 F, 0 US, plt0.01
18
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

19
CFA Success by US Experience
p NS
Ultrasound Procedures
p 0.0761 for F vs US 15
20
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.
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