Division of Vascular and Endovascular Surgery, University of California, San Francisco, Calif.
Division of Vascular Surgery and Endovascular Therapy, University of Colorado, Aurora, Colo.
J Vasc Surg. 2020 Nov;72(5):1610-1617.e1. doi: 10.1016/j.jvs.2020.01.052. Epub 2020 Mar 9.
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.
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.
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.
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.
顺行股动脉入路常用于同侧下肢外周血管介入治疗。然而，大多数器械的使用说明书仍不推荐使用闭合装置（CD）进行顺行股动脉入路（AA）。我们假设 CD 用于顺行股动脉入路不会增加血管入路并发症的发生几率。
从 2010 年到 2019 年，血管质量倡议（Vascular Quality Initiative）对通过股 AA 进行的下肢外周血管介入治疗进行了查询。排除了有切开或多个入路的患者。然后将病例分为是否使用 CD。使用控制医院层面差异的分层多变量逻辑回归来检查 CD 使用与血管入路并发症之间的独立关联。使用治疗组之间不同的因素进行了粗糙精确匹配的敏感性分析，以减少组间的不平衡。
总体而言，共确定了 11562 例病例，其中 5693 例（49.2%）使用了 CD。使用 CD 的患者不太可能是白人（74.1% vs. 75.2%），患有冠心病（29.7% vs. 33.4%），使用阿司匹林（68.7% vs. 72.4%），并接受肝素逆转剂鱼精蛋白（15.5% vs. 25.6%；均 P<.05）。CD 患者更可能肥胖（31.6% vs. 27.0%），接受择期手术（82.6% vs. 80.1%），超声引导入路（75.5% vs. 60.6%），以及更大的血管鞘（6.0±1.0 F vs. 5.5±1.0 F；均 P<.05）。与无 CD 相比，CD 病例发生任何血管入路血肿（2.55% vs. 3.53%；P<.01）或需要再次干预的血肿（0.63% vs. 1.26%；P<.01）的几率较低，血管入路狭窄或闭塞的发生率无差异（0.30% vs. 0.22%；P=.47）。多变量分析显示，CD 病例发生任何血管入路血肿的几率显著降低（比值比，0.75；95%置信区间，0.59-0.95）和需要干预的血肿几率降低（比值比，0.56；95%置信区间，0.38-0.81）。在经过粗糙精确匹配的敏感性分析后，证实了这些发现。
在这项具有全国代表性的样本中，AA 中 CD 的使用与选定患者血肿的几率降低相关。将 CD 的使用说明书适应证扩展到包括股 AA，可能会降低血管入路并发症、患者接受再次干预的几率以及对医疗保健系统的成本。
