Bystrom Philip V, Kulangara Rohan, El Khoury Rym, Piel Mitchell, Chaney Michael, Jacobs Chad E, White John V, Schwartz Lewis B
Department of Surgery, University of Illinois at Chicago, Chicago, IL.
Department of Surgery, University of Illinois at Chicago, Chicago, IL.
Ann Vasc Surg. 2025 Oct;119:111-120. doi: 10.1016/j.avsg.2025.04.127. Epub 2025 Apr 30.
Percutaneous closure of the access artery has become commonplace after endovascular intervention. In patients with peripheral vascular occlusive disease, however, control of the puncture site is more problematic as the access artery is frequently plaque-laden and stenotic. Ischemic complications in the access extremity are more common in these cases, particularly when using devices that depend on the deployment of prosthetic material within the compromised arterial lumen. The purpose of this retrospective clinical study was to assess the efficacy of totally extravascular bioresorbable closure (TEBC) of the femoral artery puncture sites after percutaneous peripheral intervention (PPI).
Consecutive PPIs performed at single institution between 2015 and 2020 were studied. Demographic characteristics and the incidence of access complications were recorded. The complication rate of TEBC and manual compression (MC) were analyzed with multivariate regression analysis. Major complications were defined as the composite of acute arterial ischemia, major bleeding, and/or pseudoaneurysm requiring operation. Minor complications were defined as the aggregate of transient hypotension, groin hematoma, and/or arteriovenous fistula.
A total of 507 PPIs were performed in 345 patients during the study period. The mean age was 74 years; comorbidities were prevalent, including diabetes (57%), obesity (28%), and end-stage renal failure requiring dialysis (10%). Indications for PPI were either chronic limb-threatening ischemia (CLTI) (68%) or claudication (32%). All procedures were performed using femoral artery access in a retrograde (93%) or antegrade (7%) fashion with ≤5 Fr (21%), 6 Fr (18%), or ≥7 Fr (61%) sheaths. Control of the femoral artery puncture site was achieved by either MC (75%), or TEBC (25%). TEBC became the exclusive closure method in 2019. Acute arterial ischemia rarely complicated MC (1.3%) but was not observed in any patient undergoing TEBC. Bleeding and/or pseudoaneurysms requiring reoperation were also rare (MC 0.3% vs. TEBC 1.6%; P = 0.64). On multivariate analysis, there was no difference in major access complications between MC and TEBC (odds ratio [OR] = 1.45 [0.27-7.79]; P = 0.66), while minor access complications were significantly reduced with the use of TEBC (OR = 0.39 [0.19-0.75]; P < 0.01).
TEBC after PPI for peripheral arterial disease is safe and effective. There were no instances of acute arterial ischemia following TEBC in this series, and TEBC significantly reduced the incidence of minor access complications compared to MC. Given the bioresorbable design of the device and the lack of an intraluminal component of any kind, TEBC may be the ideal closure device for patients with peripheral arterial disease undergoing endovascular intervention.
血管内介入治疗后，经皮闭合穿刺动脉已成为常规操作。然而，在患有外周血管闭塞性疾病的患者中，由于穿刺动脉常常伴有斑块且狭窄，穿刺部位的控制更具挑战性。在这些病例中，穿刺肢体的缺血性并发症更为常见，尤其是在使用依赖于在受损动脉腔内植入人工材料的器械时。这项回顾性临床研究的目的是评估经皮外周介入治疗（PPI）后股动脉穿刺部位完全血管外生物可吸收闭合（TEBC）的疗效。
对2015年至2020年在单一机构进行的连续PPI进行研究。记录人口统计学特征和穿刺并发症的发生率。采用多因素回归分析TEBC和手法压迫（MC）的并发症发生率。主要并发症定义为急性动脉缺血、大出血和/或需要手术治疗的假性动脉瘤的综合情况。次要并发症定义为短暂性低血压、腹股沟血肿和/或动静脉瘘的总和。
在研究期间，345例患者共进行了507次PPI。平均年龄为74岁；合并症普遍存在，包括糖尿病（57%）、肥胖（28%）和需要透析的终末期肾衰竭（10%）。PPI的适应证为慢性肢体威胁性缺血（CLTI）（68%）或间歇性跛行（32%）。所有手术均采用股动脉逆行（93%）或顺行（7%）入路，使用≤5 Fr（21%）、6 Fr（18%）或≥7 Fr（61%）的鞘管。股动脉穿刺部位的控制通过MC（75%）或TEBC（25%）实现。TEBC在2019年成为唯一的闭合方法。急性动脉缺血很少并发于MC（1.3%），但在接受TEBC的任何患者中均未观察到。需要再次手术的出血和/或假性动脉瘤也很少见（MC为0.3%，TEBC为1.6%；P = 0.64）。多因素分析显示，MC和TEBC在主要穿刺并发症方面无差异（优势比[OR] = 1.45 [0.27 - 7.79]；P = 0.66），而使用TEBC可显著降低次要穿刺并发症的发生率（OR = 0.39 [0.19 - 0.75]；P < 0.01）。
外周动脉疾病PPI后TEBC安全有效。在本系列中，TEBC后未出现急性动脉缺血的情况，且与MC相比，TEBC显著降低了次要穿刺并发症的发生率。鉴于该装置的生物可吸收设计以及缺乏任何类型的腔内组件，TEBC可能是接受血管内介入治疗的外周动脉疾病患者的理想闭合装置。
