Femoral Arterial Access With Ultrasound Trial - FAUST

Sep 25, 2009
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Trial Sponsor:
Bard Access, Inc.
Date Presented:
01/01/2009
Date Published:
01/01/2010
Date Updated:
09/25/2009
Original Posted Date:
09/25/2009
References

Description:

Although fluoroscopic guidance is routinely advocated for vascular access in patients undergoing cardiac catheterization through the femoral artery, no differences in successful common femoral artery (CFA) placement or complications have been noted in randomized trials. The current trial sought to assess whether ultrasound (US) guidance would be associated with a higher incidence of successful CFA cannulation and decreased incidence of complications, as compared with fluoroscopic guidance in patients undergoing cardiac catheterization with femoral access.

Hypothesis:

US guidance would be associated with a higher incidence of successful CFA cannulation and decreased incidence of complications, as compared with fluoroscopic guidance in patients undergoing cardiac catheterization with femoral access.

Study Design

Patients Enrolled: 1,004
Mean Follow Up: 30 days
Mean Patient Age: 63.9 years
Female: 27

Patient Populations:

  • Age ≥18 years
  • Scheduled for cardiac or peripheral angiography from retrograde femoral approach
  • Written informed consent
  • Primary operator trained in fluoroscopic and ultrasound technique

Exclusions:

  • Nonpalpable femoral pulses
  • ST-elevation myocardial infarction (STEMI) or unstable non-STEMI
  • Creatinine ≥3.0 mg/dl, unless already on dialysis
  • Prisoners
  • Pregnant women

Primary Endpoints:

  • Successful CFA cannulation

Secondary Endpoints:

Procedural:
  • First pass success rate
  • Total number of attempts
  • Accidental venipuncture
  • Time to sheath insertion

    Access complications:
    • Hematoma ≥5 cm
    • Pseudoaneurysm
    • Retroperitoneal hemorrhage
    • Arterial dissection
    • Thrombosis
    • Hemoglobin decrease ≥3g/dl with access source
    • Hemoglobin decrease ≥4g/dl without overt source
    • Non-CABG access bleeding requiring transfusion

    Drug/Procedures Used:

    Bony landmarks and femoral pulses were manually palpated prior to all procedures. US guidance was performed with a real-time freehand technique (using Site Rite [Bard Access, Inc.] to directly visualize the CFA) by a single trained operator, with an optional needle guide. In the fluoroscopic guidance arm, routine fluoroscopy was used to identify anatomical landmarks to establish the appropriate location for puncture.

    Concomitant Medications:

    Heparin (40.8%), bivalirudin (7.8%), clopidogrel (48.5%), glycoprotein IIb/IIIa inhibitors (7.6%)

Principal Findings:

A total of 1,004 patients were randomized, 503 to US guidance and 501 to fluoroscopic guidance. Baseline characteristics were fairly similar between the two arms, except for a higher incidence of smokers in the US arm. The average body mass index (BMI) was 29.7 kg/m2, with about 39.7% patients being defined as obese (BMI >30 kg/m2). Ipsilateral peripheral vascular disease (PVD) was present in about 9.1% of the patients, and a fellow-in-training was involved with most of the cases. Closure devices (most commonly AngioSeal) were employed more often in the US guidance arm (66.4% vs. 55.2%, p < 0.001).

Successful cannulation of the CFA was similar between the US and fluoroscopy guided arms (83.3% vs. 86.4%, p = 0.15), including in obese patients, and those with PVD. Patients with a high bifurcation were more likely to have successful CFA cannulation with US guidance (69.8% vs. 82.6%, p < 0.01). Other procedural outcomes such as number of attempts (3 vs. 1.3, p < 0.001), risk of venipuncture (15.8% vs. 2.4%, p < 0.001), first pass success rate (46.4% vs. 82.7%, p < 0.001), and time to sheath insertion (213 vs. 185 seconds, p = 0.016) were significantly worse in the fluoroscopic guidance arm compared with the US guidance arm. Complications such as hematoma >5 cm were also higher in the fluoroscopy guided arm (2.2% vs. 0.6%, p = 0.034). Other complications such as groin site bleeding and dissection were similar between the two arms.

Interpretation:

The results of this trial indicate that US guidance is not associated with a higher rate of successful CFA cannulation, as compared with routine fluoroscopic guidance, except in patients with a high bifurcation. There is, however, a significant reduction in other procedural outcomes such as number of attempts and risk of venipuncture, as well as a reduction in the incidence of large groin hematomas. These results are definitely interesting, since the use of US guidance is not especially technically challenging or expensive, and it also does not increase (but actually decreases) the total time required to gain groin access. US guidance is now routinely employed for venipuncture for central lines above the groin. If corroborated by other studies, US guidance should be routinely employed for femoral artery access as well. This could be of great importance in situations such as aortic valvuloplasty and percutaneous aortic valve replacement, where significantly larger bore access is necessary.

References:

Presented by Dr. Arnold Seto at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2009), San Francisco, CA, September 25, 2009.

Seto AH, Abu-Fadel MS, Sparling JM, et al. Real-time ultrasound guidance facilitates femoral arterial access and reduces vascular complications: FAUST (Femoral Arterial Access With Ultrasound Trial). JACC Cardiovasc Interv. 2010 Jul;3(7):751-8

Keywords: Fluoroscopy, Phlebotomy, Pulse, Cardiac Catheterization, Femoral Artery, Coronary Disease, Hematoma, Peripheral Vascular Diseases, Groin, Body Mass Index, Punctures, Obesity, Informed Consent


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