The Femoral Arterial Access with Ultrasound Trial FAUST

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.

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, Ph. D • Long Beach Memorial Medical Foundation

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. 2. 3. Tavris DR J Inv Cardiology 2004; 16(9): 459 -464 4. Huggins CE. J Inv Card 2009; 21(3) 105 -9 5. Jacobi JA. Proc (Bayl Univ) 2009; 22(1)7 -8 Ndrepep G et al JACC 2008; 51: 690 -697 Resnic FS et al Am J Cardiol 2007; 99: 766 – 770 6. Abu-Fadel MS. CCI 2009

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 -E 058 July 18, 2001

Site-Rite 6, Bard Access, Inc. 18 g needle guide #9001 C 0212

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 Inclusion 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 Exclusion Criteria • Nonpalpable femoral pulses • ST elevation MI or unstable non STEMI • Creatinine ≥ 3. 0 mg/d. L, unless already on dialysis • Prisoners • Pregnant women

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 • • Procedural Outcomes 1 st pass success rate Total number of attempts Accidental venipuncture Time to sheath insertion Access Complications • • • Hematoma ≥ 5 cm Pseudoaneurysm Retroperitoneal hemorrhage Arterial dissection Thrombosis Hgb ≥ 3 g/d. L w/ access source • Hgb ≥ 4 g/d. L w/o overt source • Non-CABG access bleeding requiring transfusion

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

Patient Population Fluoroscopy Ultrasound N=501 N=503 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 29. 4 30. 11 Obesity (BMI >30) 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 45 (9. 2) 45 (9. 0) 0. 92 Characteristic Age, years Body mass index (BMI) Ipsilateral PVD (50% stenosis by angio) p=NS for Creatinine, Platelet, INR, CFA diameter P-value

Procedural Characteristics Fluoroscopy Ultrasound N=501 N=503 Coronary Angiogram 460 (91. 8) 451 (89. 7) 0. 24 Peripheral Angiogram 41 (8. 2) 52 (10. 3) 0. 24 161 (32. 1) 155 (30. 8) 0. 65 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) 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) <0. 001 Characteristic Intervention Right Heart Cath * Angioseal used in 80 -83% of closures P-value

CFA Cannulation Success p = 0. 15 p = 0. 11 Fluoroscopy Ultrasound P-value 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) <0. 01 High stick p = 0. 78 p <0. 01

Procedural Outcomes p < 0. 000001 p = 0. 016 p < 0. 000001

Attending Physicians Fluoroscopy Ultrasound N=31 N=35 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 Characteristic P-value

Complications Fluoroscopy Ultrasound N=501 N=503 11 (2. 2%) 3 (0. 6%) 0. 034 Pseudoaneurysm 0 1 NS Dissection 3 2 NS Access bleeding, transfusion 2 1 NS Hematoma, DVT 1 0 NS Complication Hematoma >5 cm* Any complication 17 (3. 4%) 7 (1. 4%) *Blinded hematoma assessments: 8 F, 0 US, p<0. 01 P-value 0. 041

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= NS Ultrasound Procedures p= 0. 0761 for F vs US 15+

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%.