Objective: To evaluate the effectiveness and safety of Rotarex mechanical thrombectomy system in treating acute lower limb ischemia.
Methods: From December 2017 to December 2019, the clinical data of 23 acute lower limb ischemia cases treated with Rotarex mechanical thrombectomy system were retrospectively analyzed. There were 14 males and 9 females from 53- to 84-year-old patients and the mean age was (69.1±9.1) years. Duration of symptoms was 6 hours to 14 days (median time 7 days). In the study, 8 acute thromboembolism cases and 15 acute thrombosis cases were included (In which, there was one thromboangiitis obliterans case and two in-stent restenosis cases). In 5 cases, the lesions were located above the groin; in 16 cases, the lesions were located below the groin, and in the other 2 cases, the lesions were located both above and below the groin. All the cases were treated with Rotarex mechanical thrombectomy system. When residual stenosis was greater than 50%, percutaneous transluminal angioplasty (PTA) was used, and stent was used only when it was necessary. Heparin was used 24 h after the procedure, and after that, antiplatelet agents were used in acute thrombosis cases, and oral anti-coagulants were used in acute thromboembolism cases. Doppler ultrasonography was taken during the follow-up.
Results: In all the 23 cases, there were 22 successful cases and 1 unsuccessful case, the mean procedure time was (68.2±15.6) min. Percutaneous transluminal angioplasty was used in 18 cases, 7 of which were implanted stents (3 stents were implanted in iliac artery and 4 in superficial femoral artery). There were 3 procedure related complications. The first one was arterial wall injury which resulted in contrast medium extravazation, and in this case, we solved it with prolonged balloon inflation. The second one was distal embolism. We took out the thrombus with guiding catheter. The last one was acute occlusion in a stent, and thrombectomy was applied urgently, and the result was good. Mean hospital stay were (3.6±1.7) days. The ankle brachial index (ABI) increased from 0.25±0.10 to 0.85±0.16 after treatment (t=12.901, P < 0.001). All the patients were followed up for 4.0-28.0 months, and the median time was 12.0 months. One patient stopped antiplatelet agents, which resulted in acute thrombosis 2 months later. Another percutaneous mechanical thrombectomy and PTA were taken. In the failed case, the patient suffered amputation above the knee 3 months later and in another case, the patient died of heart failure 8 months after the procedure. Two target lesion restenosis occurred during the follow-up. Because the patients' symptom was not sever, no procedure was taken.
Conclusion: Percutaneous mechanical thrombectomy using Rotarex catheter is safe and effective in treating acute lower limb ischemia. For one side, it can restore blood flow to the affected limbs quickly, and for the other, it has the characteristics of minimally invasive and good repeatability. So it should be considered that this me-thod can be widely used for acute lower limb ischemia.
目的: 探讨应用Rotarex旋切导管行经皮机械性血栓切除在治疗急性下肢缺血中的有效性和安全性。
方法: 回顾性分析2017年12月至2019年12月应用Rotarex旋切导管行经皮机械性血栓切除治疗的23例急性下肢缺血患者的临床资料，男14例、女9例，年龄53.0~84.0岁，平均(69.1±9.1)岁，病史6 h至14 d(中位时间7 d)。其中，动脉栓塞8例，急性血栓形成15例(血栓闭塞性脉管炎1例，支架内再狭窄2例)；病变位于腹股沟以上者5例，腹股沟以下者16例，同时累及腹股沟上下者2例。所有患者均应用Rotarex旋切导管行经皮机械性血栓切除，残余狭窄大于50%的患者同期行腔内成形术，必要时植入支架。术后肝素抗凝24 h后对动脉栓塞患者抗凝治疗，对动脉狭窄基础上继发急性血栓形成的患者行抗血小板治疗，定期彩色超声复查随访。
结果: 23例患者中22例血运重建成功，1例失败，平均手术时间(68.2±15.6) min。18例患者行动脉腔内成形术；7例患者植入支架，其中3例为髂动脉支架，4例为股浅动脉支架。手术相关并发症3例，其中造影剂外溢1例，以球囊贴附后无造影剂外溢；远端栓塞1例，以8F导引导管抽吸的方法取出栓子；髂动脉支架急性闭塞1例，急诊行股动脉切开取栓术，术后恢复良好。该组患者平均住院时间(3.6±1.7) d，出院时踝肱指数(ankle brachial index，ABI)较术前明显改善(0.85±0.16 vs. 0.25±0.10，t=12.901，P < 0.001)。随访4~28个月，中位随访时间12个月，随访期间1例患者因自行停用抗血小板药物，术后2个月时下肢缺血症状复发，再次行经皮机械性血栓切除及动脉腔内成形重建血运。1例术后3个月行膝上截肢(失败病例)，1例术后8个月死于心衰。2例患者随访期间超声提示靶病变再狭窄大于50%，因症状不明显，未再次手术治疗。
结论: 对于急性下肢缺血，采用Rotarex旋切导管行经皮机械性血栓切除是一种安全有效的治疗方法，一方面能够快速重建患肢血运，另一方面具有微创和可重复性好的特点，适宜在临床推广应用。
Keywords: Acute disease; Endovascular procedures; Ischemia; Lower extremity; Thrombectomy.