Department of Surgery, Division of Vascular and Endovascular Surgery, University of California, San Francisco, CA, USA.
Department of Surgery, Division of Vascular and Endovascular Therapy, University of Colorado, Aurora, CO, USA.
Ann Vasc Surg. 2021 Oct;76:49-58. doi: 10.1016/j.avsg.2021.03.009. Epub 2021 Apr 7.
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).
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.
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.
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.
尽管许多设备的使用说明书中并未提及使用闭合装置(CD)进行股动脉顺行入路(AA),但据报道,与单独手动压迫相比,AA 与较低的入路部位并发症发生率相关。我们假设与逆行入路(RA)相比,CD 用于 AA 不会导致临床意义上的入路部位并发症风险增加。
这是一项对 2010 年至 2019 年血管质量倡议中进行下肢外周血管介入治疗且使用 CD 闭合股总动脉的回顾性研究。排除接受切开或多入路的患者。然后根据入路是顺行还是逆行将病例分层。使用控制医院水平差异的分层多变量逻辑回归来检查 AA 与入路部位并发症之间的独立关联。主要结局为血管质量倡议中定义的入路部位血肿、狭窄或闭塞。次要结局为需要介入治疗的入路部位血肿,定义为输血、凝血酶注射或手术。进行了粗糙精确匹配后的敏感性分析,以减少残余偏倚。
总体而言,共确定了 72463 例患者,其中 6070 例(8.4%)为 AA。AA 患者中吸烟者比例较低(27.2%比 33.0%;均 P<0.05)或肥胖者比例较低(31.5%比 35.6%;均 P<0.05)。AA 患者更可能接受透析治疗(12.8%比 10.1%)和接受超声引导入路(76.4%比 66.2%;均 P<0.05)。与 RA 相比,AA 患者发生任何入路部位血肿的风险更高(2.5%比 1.8%;P<0.01),且需要干预的血肿风险更高(0.7%比 0.5%;P=0.03),但入路部位狭窄或闭塞发生率无差异(0.3%比 0.2%;P=0.21)。多变量分析显示,AA 发生任何入路部位血肿的风险增加(OR=1.46;95%CI=1.22-1.76)和需要干预的血肿风险增加(OR=1.48;95%CI=1.10-1.98)。粗糙精确匹配后的敏感性分析证实了这些发现。
在这项具有全国代表性的样本中,使用 CD 进行股动脉入路与总体较低的入路部位并发症发生率相关。然而,AA 与入路部位血肿的风险增加相关。AA 的患者选择仍然很重要,超声引导入路应该是该方法的标准治疗方法。