Presentation is loading. Please wait.

Presentation is loading. Please wait.

The Femoral Arterial Access with Ultrasound Trial (FAUST) A prospective randomized controlled trial of ultrasound guidance versus standard fluoroscopic.

Similar presentations


Presentation on theme: "The Femoral Arterial Access with Ultrasound Trial (FAUST) A prospective randomized controlled trial of ultrasound guidance versus standard fluoroscopic."— Presentation transcript:

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 investigatorLead investigator Arnold Seto, MD, MPAArnold Seto, MD, MPA Co-Principal InvestigatorsCo-Principal Investigators Mazen Abu-Fadel, MD, University of Oklahoma HSCMazen Abu-Fadel, MD, University of Oklahoma HSC Morton Kern, MD, UC-Irvine Medical Center and Long Beach VAMorton Kern, MD, UC-Irvine Medical Center and Long Beach VA Co-InvestigatorsCo-Investigators Jeffrey Sparling, Soni Zacharias, Timothy Daly, Thomas HennebryJeffrey Sparling, Soni Zacharias, Timothy Daly, Thomas Hennebry Alexander Harrison, Will Suh, Jesus Vera, Pranav Patel, Rex WintersAlexander Harrison, Will Suh, Jesus Vera, Pranav Patel, Rex Winters Clinical Trials IdentifierClinical Trials Identifier NCT 00667381NCT 00667381 Supported bySupported by General Clinical Research Center at OUHSC, Chris Aston, PhDGeneral Clinical Research Center at OUHSC, Chris Aston, PhD Long Beach Memorial Medical FoundationLong Beach Memorial Medical Foundation Lead investigatorLead investigator Arnold Seto, MD, MPAArnold Seto, MD, MPA Co-Principal InvestigatorsCo-Principal Investigators Mazen Abu-Fadel, MD, University of Oklahoma HSCMazen Abu-Fadel, MD, University of Oklahoma HSC Morton Kern, MD, UC-Irvine Medical Center and Long Beach VAMorton Kern, MD, UC-Irvine Medical Center and Long Beach VA Co-InvestigatorsCo-Investigators Jeffrey Sparling, Soni Zacharias, Timothy Daly, Thomas HennebryJeffrey Sparling, Soni Zacharias, Timothy Daly, Thomas Hennebry Alexander Harrison, Will Suh, Jesus Vera, Pranav Patel, Rex WintersAlexander Harrison, Will Suh, Jesus Vera, Pranav Patel, Rex Winters Clinical Trials IdentifierClinical Trials Identifier NCT 00667381NCT 00667381 Supported bySupported by General Clinical Research Center at OUHSC, Chris Aston, PhDGeneral Clinical Research Center at OUHSC, Chris Aston, PhD Long Beach Memorial Medical FoundationLong Beach Memorial Medical Foundation

3 Background 1.Tavris DR J Inv Cardiology 2004; 16(9):459-464 2.Ndrepep G et al JACC 2008;51:690-697 3.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 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

4 Ultrasound guidance in Venous Access 1. BMJ. 2003 August 16; 327(7411): 361 2. AHRQ Publication 01-E058 July 18, 2001 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.

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 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 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 Secondary Endpoints 1 st 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 Procedural Outcomes Access Complications

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

12 Patient PopulationCharacteristicFluoroscopyN=501UltrasoundN=503P-value Age, years 64.263.50.33 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) 29.430.10.11 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 Ipsilateral PVD (50% stenosis by angio) 45 (9.2) 45 (9.0) 0.92 p=NS for Creatinine, Platelet, INR, CFA diameter

13 Procedural CharacteristicsCharacteristicFluoroscopyN=501UltrasoundN=503P-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) 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 * Angioseal used in 80-83% of closures

14 CFA Cannulation SuccessFluoroscopyUltrasoundP-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) <0.01 p = 0.15 p <0.01 p = 0.78 p = 0.11

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

16 Attending PhysiciansCharacteristicFluoroscopyN=31UltrasoundN=35P-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 ComplicationsComplicationFluoroscopyN=501UltrasoundN=503P-value Hematoma >5 cm* 11 (2.2%) 3 (0.6%) 0.034 Pseudoaneurysm01NS Dissection32NS Access bleeding, transfusion 21NS Hematoma, DVT 10NS Any complication 17 (3.4%) 7 (1.4%) 0.041 *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 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%.


Download ppt "The Femoral Arterial Access with Ultrasound Trial (FAUST) A prospective randomized controlled trial of ultrasound guidance versus standard fluoroscopic."

Similar presentations


Ads by Google