Closure device use for common femoral artery antegrade access is higher risk than retrograde access

Ann Vasc Surg. 2021 Oct:76:49-58. doi: 10.1016/j.avsg.2021.03.009. Epub 2021 Apr 7.

Abstract

Objective: Although the use of closure devices (CD) for femoral artery antegrade access (AA) is not in the instructions for use (IFU) for many devices, AA has been reported to be associated with a lower incidence of access site complications compared to manual compression alone. We hypothesized that CD use for AA would not be associated with a clinically significant increased odds of access site complications compared to CD use for retrograde access (RA).

Methods: This was a retrospective review of the Vascular Quality Initiative from 2010 to 2019 for infrainguinal peripheral vascular interventions with common femoral artery access closed with a CD. Patients who had a cutdown or multiple access sites were excluded. Cases were then stratified into whether access was antegrade or retrograde. Hierarchical multivariable logistic regressions controlling for hospital level variation were used to examine the independent association between AA and access site complications. The primary outcomes were access site hematoma, stenosis, or occlusion as defined in the VQI. The secondary outcome was the development of an access site hematoma requiring an intervention, which was defined as transfusion, thrombin injection, or surgery. Sensitivity analyses after coarsened exact matching were performed to reduce residual bias.

Results: Overall, 72,463 cases were identified and 6,070 (8.4%) had AA. Patients with AA were less likely to be smokers (27.2% vs 33.0%) or obese (31.5% vs 35.6%; all P<0.05). Patients with AA were more likely to be on dialysis (12.8% vs 10.1%) and have ultrasound-guided access (76.4% vs 66.2%; P<0.05 for all). Compared to RA, patients with AA were more likely to develop any access site hematoma (2.5% vs 1.8%; P<0.01) and a hematoma requiring intervention (0.7% vs 0.5%; P=0.03), but had no difference in access site stenosis or occlusion (0.3% vs 0.2%; P=0.21). On multivariable analyses, AA had increased odds of developing any access site hematoma (OR=1.46; 95% CI=1.22-1.76) and a hematoma requiring intervention (OR=1.48; 95% CI=1.10-1.98). Sensitivity analyses after coarsened exact matching confirmed these findings.

Conclusion: In this nationally representative sample, the use of CDs for femoral access was associated with an overall low rate of access site complications. However, there was an increased odds of access site hematomas with AA. Patient selection for AA remains important and ultrasound guided access should be the standard of care for this approach.

Keywords: Access site complications; Access site hematomas; Antegrade arterial access; Arterial closure device; Endovascular surgery; Lower extremity peripheral arterial interventions; Retrograde arterial access.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Catheterization, Peripheral* / adverse effects
  • Databases, Factual
  • Female
  • Femoral Artery*
  • Hematoma / etiology
  • Hemorrhage / etiology
  • Hemorrhage / prevention & control*
  • Hemostatic Techniques / adverse effects
  • Hemostatic Techniques / instrumentation*
  • Humans
  • Male
  • Middle Aged
  • Punctures
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Vascular Closure Devices*