Perclose缝合器与Boomerang血管封阻器对股动脉穿刺点的止血效应:与人工压迫法比较

Perclose and Boomerang arterial puncture closing devices for hemostasis at the femoral artery puncture point:Comparison with manual compression

目的:观察冠状动脉造影术及支架置入术后应用两种血管穿刺闭合器在股动脉径路止血中的安全性和有效性,其结果与人工压迫止血方法对照。方法:①实验对象:选择2006-03/2007-08在解放军空军总医院心内科住院的临床疑诊冠心病或确诊冠心病行冠状动脉造影或冠状动脉介入治疗的患者436例,男246例,女190例,年龄44～75岁,平均(62.4±12.5)岁。所有患者对治疗和实验均知情同意。分为人工压迫止血组160例,Boomerang封堵器组140例,Perclose缝合器组136例。②实验仪器:Boomerang血管封堵器由美国Cardiva公司生产(产品批号:610070521A,型号:B610),Perclose缝合装置由美国Abott公司生产(产品批号:54145-6H,型号:12673)。③实验方法:a:压迫止血法:冠状动脉造影后立即拔除鞘管,局部压迫止血;经皮冠状动脉介入术患者术后送回病房,4h后测活化部分凝血活酶时间达65s以下时拔除鞘管,局部压迫止血。b:Boomerang封堵器法:严格按操作规范置入血管封堵器,在血管内留置时间依术中肝素量不同而不同。c:Perclose缝合器法:严格按操作规范缝合穿刺点血管。④实验评估:记录止血时间,指从拔除动脉鞘管到穿刺部位无出血的时间;制动时间,指从手术结束到患者下地活动时间;观察有无血管并发症,包括穿刺部位局部血肿(直径>5cm)、穿刺口渗血、假性动脉瘤、血栓形成、动静脉瘘、血管迷走反射等;计算止血成功率。结果:共纳入观察患者436例,均进入结果分析。结果发现Boomerang封堵器组止血成功率96.4%,Perclose缝合器组止血成功率90.5%;不论单纯冠状动脉造影还是介入治疗,两组患者与人工压迫法比较止血时间及下肢制动时间均显著缩短(P<0.05,P<0.01);介入治疗中,Perclose缝合器血管并发症发生率为5.2%,Boomerang封堵器为5.7%,均较人工压迫组(14.7%)明显减少(P均<0.05)。结论:Perclose缝合器与Boomerang封堵器用于股动脉穿刺后止血迅速、有效、安全,止血时间、制动时间及血管并发症发生率均明显优于人工压迫法止血,且不存在特殊生物相容性问题。

AIM： To retrospective study the safety and efficacy of two arterial puncture closing devices, Perclose and Boomerang, for hemostasis at the femoral artery puncture point in patients undergoing coronary angiography （CAG） or percutaneous coronary interventions （PCI）, and compare it with standard manual compression. METHODS： ①From March 2006 to August 2007, 436 inpatients who were diagnosed or suspected coronary artery disease and treated with CAG or PCI at Department of Cardiology, General Hospital of Air Force were selected, including 246 males and 190 females, with an average age of （62.4±12.5） years （range, 44-75 years）. The informed consent was obtained from all subjects. They were divided into manual compression group （n =160）, Boomerang group （n =140）, and Perclose group （n =136）. ②Boomerang puncture closing device was produced by Cardiva Company of USA （Lot number： 610070521A, Pattern number： B610）. Perclose puncture closing device was product of Abott Company of USA （Lot number： 54145-6H, Pattern number： 12673）. ③In compression hemostasis, the sheath was pulled out immediately after CAG, then the femoral artery puncture point was compressed by hand; After PCI, the patients were sent back, and the sheath was pulled out when the activated partial thromboplastin time （APTT） was below 65 seconds. In the method of Boomerang, Boomerang arterial puncture closing devices were put according to the operation specification strictly, the time of the device placed in femoral artery was changed with the dose of heparin during operation. In the methods of Perclose, the femoral artery puncture point was sutured according to the operation specification strictly. ④The hemostasis time that from the sheath pulled out to the femoral artery puncture point stop bleeding and leg immobilization time from the end of operation to the beginning of mobilization was recorded. The vascular complications were observed including hematom （diameter 〉 5 cm） and exudative hemorrhage of the puncture locus, false aneurysm, thrombosis, arteriovenous fistula, vagus nerve reflexum, etc. The success rate of achieving hemostasis was calculated. RESULTS： Totally 436 patients were enrolled and all were involved in the result analysis. The success rate completely by Boomerang vascular closure device was 96.4%, and by Perclose was 90.5%. Time for hemostasis and leg immobilization in Boomerang group and Perclose group was decreased significantly compared with the manual group （P 〈 0.05, P 〈 0.01）. After PCI, the incidences of major vascular complications in Perclose group （5.2%） and Boomerang group （5.7%） were both decreased significantly compared with that in manual group （14.7%）, （both P 〈 0.05）. CONCLUSION： Hemostasis with Boomerang and Perclose arterial puncture closing devices after CAG or PCI both are very fast, effective and safe. The time for hemostasis and leg immobilization and the incidence of vascular complication are better than those of manual compression obviously. Furthermore, there is no special biocompatibility.