Arnold Seto, MD, MPA University of California, Irvine TCT Late Breaking Trial Presentation September 25, 2009

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 • 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

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 5, Bard Access, Inc. 18g needle guide #9001C0212

6. The goal

7. 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

8. 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 Entry Criteria Inclusion Criteria Exclusion Criteria

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 > 30) • PVD

10. 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 Secondary Endpoints Procedural Outcomes Access Complications

11. Enrolled, Randomized N=1015 Canceled procedure (3) Change in approach (2) Excluded after randomization N=11 No trained operator (4) STEMI No Pulses Fluoroscopy N=501 Ultrasound N=503 Crossover to US N=5 Needle guide N=454 Freehand N=28 Not real time N=21 No Femoral Angiogram N=11 No Femoral Angiogram N=4 Fluoroscopy Angios N=490 Ultrasound Angios N=499

12. Patient Population p=NS for Creatinine, Platelet, INR, CFA diameter

13. Procedural Characteristics * Angioseal used in 80-83% of closures

14. CFA Cannulation Success p = 0.15 p = 0.11 p = 0.78 p <0.01

15. Procedural Outcomes p < 0.000001 p < 0.000001 p = 0.016 p < 0.000001

16. Attending Physicians

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

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 UltrasoundProcedures p= 0.0761 for F vs US 15+

20. 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%.

21. 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