ExoSeal血管封堵器在急性缺血性脑卒中桥接治疗中的安全性和有效性

Safety and efficacy of ExoSeal vascular occluder in bridging therapy for acute ischemic stroke

目的 探讨ExoSeal血管封堵器在接受桥接治疗的急性缺血性脑卒中(AIS)患者中的安全性和有效性。方法 回顾性分析2018年6月至2020年12月在潍坊市人民医院接受全量重组组织型纤溶酶原激活剂(rt-PA)溶栓后桥接血管腔内机械取栓治疗的142例AIS患者临床资料。所有患者在血管腔内机械取栓手术时均使用8 F股动脉鞘,术毕股动脉穿刺点由指压法封堵68例,7 F ExoSeal封堵器封堵74例。比较指压法组和封堵器组股动脉穿刺点封堵成功率及穿刺点相关并发症发生率。结果 封堵器组与指压法组相比,手术成功率显著增高(94.6%比83.8%,P=0.037)。指压法组、封堵器组患者术后至出院前分别有11例(16.2%)、4例(5.4%)发生穿刺点相关并发症(P=0.030),6例(8.8%)、2例(2.7%)发生深静脉血栓(P=0.109),均未发生动静脉瘘、假性动脉瘤、同侧下肢急性缺血、穿刺点相关大出血及需要血管外科手术或介入治疗的并发症。结论 ExoSeal封堵器可安全地应用于溶栓后桥接血管腔内机械取栓治疗的AIS患者,股动脉穿刺点封堵成功率较高,且降低穿刺点血肿发生率。

Objective To investigate the safety and efficacy of ExoSeal vascular occluder in bridging therapy for patients with acute ischemic stroke(AIS).Methods The clinical data of 142 AIS patients,who received mechanical thrombectomy in the bridge-connected vascular lumen after full dose recombinant tissue plasminogen activator(rt-PA) thrombolysis at the Weifang Municipal People's Hospital of China between June2018 and December 2020,were retrospectively analyzed.An 8-F femoral arterial sheath was used for the performance of endovascular mechanical thrombectomy in all patients.After the interventional procedure finished,the hemostasis of femoral artery puncture point was achieved by using manual compression(MC)method in 68 patients(MC group) and by using a 7-F ExoSeal vascular occluder method in 74 patients(ExoSeal group).The success rate of puncture point hemostasis and the incidence of puncture point-related complications were compared between the two methods.Results The success rate of surgery in the ExoSeal group was 94.6%,which was obviously higher than 83.8% in the MC group(P=0.037).During the period from the time of finishing surgery and the time of discharge,11 patients(16.2%) in the MC group and 4 patients(5.4%)in the ExoSeal group developed puncture point-related complications(P=0.030),and 6 patients(8.8%) in the MC group and 2 patients(2.7%) in the ExoSeal group developed deep vein thrombosis(P=0.109).No arteriovenous fistula,pseudoaneurysm,acute ischemia of the ipsilateral lower limb,puncture point-associated major bleeding,or other complications that required vascular surgery or interventional therapy occurred in all patients.Conclusion ExoSeal vascular closure device can be safely used in AIS patients who are receiving mechanical thrombectomy in the bridge-connected vascular lumen after thrombolysis.It carries high success rate for femoral artery puncture point hemostasis,besides,it can reduce the incidence of puncture point hematoma.