TY - JOUR
T1 - Antegrade common femoral artery closure device use is associated with decreased complications
AU - Ramirez, Joel L.
AU - Zarkowsky, Devin S.
AU - Sorrentino, Thomas A.
AU - Hicks, Caitlin W.
AU - Vartanian, Shant M.
AU - Gasper, Warren J.
AU - Conte, Michael S.
AU - Iannuzzi, James C.
N1 - Funding Information:
Supported by institutional start-up funds (J.C.I.) with additional student research support from the Society for Vascular Surgery Student Research Fellowship Award and the American Heart Association Student Scholarship (J.L.R.). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Society for Vascular Surgery or American Heart Association. The funding organizations were not involved in the design and conduct of the study, collection, management, analysis, and interpretation of the data, or preparation, review or approval of the manuscript.
Publisher Copyright:
© 2020
PY - 2020/11
Y1 - 2020/11
N2 - Objective: Antegrade femoral artery access is often used for ipsilateral infrainguinal peripheral vascular intervention. However, the use of closure devices (CD) for antegrade access (AA) is still considered outside the instructions for use for most devices. We hypothesized that CD use for antegrade femoral access would not be associated with an increased odds of access site complications. Methods: The Vascular Quality Initiative was queried from 2010 to 2019 for infrainguinal peripheral vascular interventions performed via femoral AA. Patients who had a cutdown or multiple access sites were excluded. Cases were then stratified into whether a CD was used or not. Hierarchical multivariable logistic regressions controlling for hospital-level variation were used to examine the independent association between CD use and access site complications. A sensitivity analysis using coarsened exact matching was performed using factors different between treatment groups to reduce imbalance between the groups. Results: Overall, 11,562 cases were identified and 5693 (49.2%) used a CD. Patients treated with a CD were less likely to be white (74.1% vs 75.2%), have coronary artery disease (29.7% vs 33.4%), use aspirin (68.7% vs 72.4%), and have heparin reversal with protamine (15.5% vs 25.6%; all P <.05). CD patients were more likely to be obese (31.6% vs 27.0%), have an elective operation (82.6% vs 80.1%), ultrasound-guided access (75.5% vs 60.6%), and a larger access sheath (6.0 ± 1.0 F vs 5.5 ± 1.0 F; P <.05 for all). CD cases were less likely to develop any access site hematoma (2.55% vs 3.53%; P <.01) or a hematoma requiring reintervention (0.63% vs 1.26%; P <.01) and had no difference in access site stenosis or occlusion (0.30% vs 0.22%; P =.47) compared with no CD. On multivariable analysis, CD cases had significantly decreased odds of developing any access site hematoma (odds ratio, 0.75; 95% confidence interval, 0.59-0.95) and a hematoma requiring intervention (odds ratio, 0.56; 95% confidence interval, 0.38-0.81). A sensitivity analysis after coarsened exact matching confirmed these findings. Conclusions: In this nationally representative sample, CD use for AA was associated with a lower odds of hematoma in selected patients. Extending the instructions for use indications for CDs to include femoral AA may decrease the incidence of access site complications, patient exposure to reintervention, and costs to the health care system.
AB - Objective: Antegrade femoral artery access is often used for ipsilateral infrainguinal peripheral vascular intervention. However, the use of closure devices (CD) for antegrade access (AA) is still considered outside the instructions for use for most devices. We hypothesized that CD use for antegrade femoral access would not be associated with an increased odds of access site complications. Methods: The Vascular Quality Initiative was queried from 2010 to 2019 for infrainguinal peripheral vascular interventions performed via femoral AA. Patients who had a cutdown or multiple access sites were excluded. Cases were then stratified into whether a CD was used or not. Hierarchical multivariable logistic regressions controlling for hospital-level variation were used to examine the independent association between CD use and access site complications. A sensitivity analysis using coarsened exact matching was performed using factors different between treatment groups to reduce imbalance between the groups. Results: Overall, 11,562 cases were identified and 5693 (49.2%) used a CD. Patients treated with a CD were less likely to be white (74.1% vs 75.2%), have coronary artery disease (29.7% vs 33.4%), use aspirin (68.7% vs 72.4%), and have heparin reversal with protamine (15.5% vs 25.6%; all P <.05). CD patients were more likely to be obese (31.6% vs 27.0%), have an elective operation (82.6% vs 80.1%), ultrasound-guided access (75.5% vs 60.6%), and a larger access sheath (6.0 ± 1.0 F vs 5.5 ± 1.0 F; P <.05 for all). CD cases were less likely to develop any access site hematoma (2.55% vs 3.53%; P <.01) or a hematoma requiring reintervention (0.63% vs 1.26%; P <.01) and had no difference in access site stenosis or occlusion (0.30% vs 0.22%; P =.47) compared with no CD. On multivariable analysis, CD cases had significantly decreased odds of developing any access site hematoma (odds ratio, 0.75; 95% confidence interval, 0.59-0.95) and a hematoma requiring intervention (odds ratio, 0.56; 95% confidence interval, 0.38-0.81). A sensitivity analysis after coarsened exact matching confirmed these findings. Conclusions: In this nationally representative sample, CD use for AA was associated with a lower odds of hematoma in selected patients. Extending the instructions for use indications for CDs to include femoral AA may decrease the incidence of access site complications, patient exposure to reintervention, and costs to the health care system.
KW - Access site complications
KW - Antegrade access
KW - Closure devices
KW - Femoral access
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U2 - 10.1016/j.jvs.2020.01.052
DO - 10.1016/j.jvs.2020.01.052
M3 - Article
C2 - 32165058
AN - SCOPUS:85081246204
VL - 72
SP - 1610-1617.e1
JO - Journal of Vascular Surgery
JF - Journal of Vascular Surgery
SN - 0741-5214
IS - 5
ER -