Ultrasound-guided femoral access in patients with vascular closure devices: a prespecified analysis of the randomised UNIVERSAL trial

DOI: 10.4244/EIJ-D-22-01130

Marc-André d'Entremont
Marc-André d'Entremont1,2, MD, MPH; Sulaiman Alrashidi3,4,5, MD; Omar Alansari3,4,5, MD; Bradley Brochu6, MD; Laura Heenan2, MSc; Elizabeth Skuriat2, MSc; Jessica Tyrwhitt2, BSc; Micheal Raco3,4,5, MD; Micheal Tsang3,4,5, MD, MSc; Nicholas Valettas3,4,5, MD, MASc; James L. Velianou3,4,5, MD; Tej N. Sheth2,3,4,5, MD; Matthew Sibbald3,4,5, MD, PhD; Shamir R. Mehta2,3,4,5, MD, MSc; Natalia Pinilla-Echeverri2,3,4,5, MD, MSc; Jon David Schwalm2,3,4,5, MD, MSc; Madhu K. Natarajan2,3,4,5, MD, MSc; Andrew Kelly3,4,5, MD; Elie Akl7, MD; Sarah Tawadros4, MBBCh; Mercedes Camargo4, MD, MASc; Walaa Faidi4, MSc; John Bauer4, BMRSc; Rachel Moxham4, BSc; James Nkurunziza3,4,5, MD; Gustavo Dutra3,4, MD; Jose Winter8, MD; Sanjit S. Jolly2,3,4,5, MD, MSc
1. Centre Hospitalier Universitaire de Sherbrooke (CHUS), Sherbrooke, QC, Canada; 2. Population Health Research Institute, Hamilton, ON, Canada; 3. McMaster University, Hamilton, ON, Canada; 4. Hamilton Health Sciences, Hamilton, ON, Canada; 5. Niagara Health, St. Catharines, ON, Canada; 6. CK Hui Heart Centre, Royal Alexandra Hospital, Edmonton, AB, Canada; 7. McGill University Faculty of Medicine and Health Sciences, Montreal, QC, Canada; 8. Clinica Alemana De Santiago, Universidad de Desarrollo, Santiago, Chile

Background: Whether ultrasound (US)-guided femoral access compared to femoral access without US guidance decreases access site complications in patients receiving a vascular closure device (VCD) is unclear.

Aims: We aimed to compare the safety of VCD in patients undergoing US-guided versus non-US-guided femoral arterial access for coronary procedures.

Methods: We performed a prespecified subgroup analysis of the UNIVERSAL trial, a multicentre randomised controlled trial of 1:1 US-guided femoral access versus non-US-guided femoral access, stratified for planned VCD use, for coronary procedures on a background of fluoroscopic landmarking. The primary endpoint was a composite of major Bleeding Academic Research Consortium 2, 3 or 5 bleeding and vascular complications at 30 days.

Results: Of 621 patients, 328 (52.8%) received a VCD (86% ANGIO-SEAL, 14% ProGlide). In patients who received a VCD, those randomised to US-guided femoral access compared to non-US-guided femoral access experienced a reduction in major bleeding or vascular complications (20/170 [11.8%] vs 37/158 [23.4%], odds ratio [OR] 0.44, 95% confidence interval [CI]: 0.23-0.82). In patients who did not receive a VCD, there was no difference between the US- and non-US-guided femoral access groups, respectively (20/141 [14.2%] vs 13/152 [8.6%], OR 1.76, 95% CI: 0.80-4.03; interaction p=0.004).

Conclusions: In patients receiving a VCD after coronary procedures, US-guided femoral access was associated with fewer bleeding and vascular complications compared to femoral access without US guidance. US guidance for femoral access may be particularly beneficial when VCD are used.

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access sitebleedingfemoral
Peripheral interventionsIliac / Femoral / PoplitealVascular access and bleeding
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