Division of Vascular Medicine, Medical Clinic and Policlinic IV, Hospital of the Ludwig-Maximilians-University, Pettenkoferstrasse 8a, 80336, Munich, Germany.
Clinic and Policlinic for Radiology, Hospital of the Ludwig-Maximilians-University, Munich, Germany.
Cardiovasc Intervent Radiol. 2021 May;44(5):700-708. doi: 10.1007/s00270-020-02717-w. Epub 2020 Dec 6.
To evaluate the safety and efficacy of a filter embolic protection device (FEPD) in endovascular interventions of the femoropopliteal arteries.
Patients who underwent endovascular interventions of the femoropopliteal arteries between 2008 and 2016 and in whom the SpiderFX FEPD was applied were included in this retrospective study. Clinical and angiographic characteristics, filter macroembolization (FME), device-related complications, distal embolization, as well as the early clinical and hemodynamic outcome, were assessed. Potential risk factors for FME were evaluated by multivariate analysis.
A total of 244 cases were identified (203 patients, claudication 60.4%, critical limb ischaemia 39.6%, mean lesion length 13.2 ± 12.9 cm, complete occlusions in 72.7%). Balloon angioplasty ± stenting (BAP), directional atherectomy ± balloon angioplasty ± stenting (DA) and rotational thrombectomy ± balloon angioplasty ± stenting (RT) were performed in 141, 61 and 42 cases, respectively. FEPD placement and retrieval were successful in all but one case each. Permanent filter-related vessel damage was not observed. The rate of FME was 37.3% (BAP 36.2%, DA 32.8%, RT 47.7%). Risk factors for FME in the BAP- and DA-group were total occlusion, lesion length > 19 cm, visible thrombus and diabetes mellitus. The distal embolization rate despite filter protection was 4.1 % (BAP 4.9%, DA 1.6%, RT 4.8%) and was higher in cases with FME compared with those without FME (8.7% vs. 1.5%, p = 0.02).
The Spider FX device is safe and effective in capturing embolic debris during femoropopliteal interventions. A residual risk of peripheral embolization remains.
III, Cohort study.
评估滤器栓塞保护装置（FEPD）在股腘动脉血管内介入治疗中的安全性和疗效。
本回顾性研究纳入了 2008 年至 2016 年期间接受股腘动脉血管内介入治疗且应用 SpiderFX FEPD 的患者。评估了临床和血管造影特征、滤器内大块栓塞（FME）、与器械相关的并发症、远端栓塞以及早期临床和血液动力学结果。通过多变量分析评估了 FME 的潜在危险因素。
共确定了 244 例病例（203 例患者，跛行 60.4%，严重肢体缺血 39.6%，平均病变长度 13.2±12.9cm，完全闭塞 72.7%）。球囊血管成形术±支架置入术（BAP）、定向旋切术±球囊血管成形术±支架置入术（DA）和旋转血栓切除术±球囊血管成形术±支架置入术（RT）分别在 141、61 和 42 例中进行。除各有 1 例外，FEPD 放置和取出均成功。未观察到永久性滤器相关血管损伤。FME 发生率为 37.3%（BAP 为 36.2%，DA 为 32.8%，RT 为 47.7%）。BAP 和 DA 组中 FME 的危险因素为完全闭塞、病变长度>19cm、可见血栓和糖尿病。尽管进行了滤器保护，仍有 4.1%（BAP 为 4.9%，DA 为 1.6%，RT 为 4.8%）发生远端栓塞，且有 FME 的患者发生率高于无 FME 的患者（8.7%比 1.5%，p=0.02）。
Spider FX 装置在股腘动脉介入治疗中捕获栓塞碎片是安全有效的。外周栓塞的残余风险仍然存在。
III 级，队列研究。
