三种血管闭合器Starclose,Perclose和Boomerang在股动脉穿刺止血中的应用

Application of femoral artery closure devices Starclose,Perclose and Boomerang in femoral hemostasis

背景:随着血管闭合器广泛应用于经股动脉途径介入手术,如何客观评价和合理应用这些闭合器值得关注。目的:对比观察冠状动脉造影和经皮冠状动脉介入治疗后应用3种股动脉血管穿刺闭合器与人工压迫止血方法的安全性和有效性。设计、时间及地点:随机分组设计,对比观察,病例来自2006-03/2008-07解放军空军总医院心内科。对象和材料:选择解放军空军总医院心内科收治的行冠状动脉造影380例和经皮冠状动脉介入治疗538例的患者共918例,男562例,女356例,年龄24～83岁。Starclose血管闭合系统和Perclose缝合装置由美国Abott公司生产,Boomerang血管封堵器由美国Cardiva公司生产。方法:918例患者按止血方法分为4组。人工压迫止血组(n=271):采用压迫止血,冠状动脉造影后立即拔除鞘管,局部压迫止血;经皮冠状动脉介入治疗后活化凝血活酶时间降至65s以下时拔管压迫止血10～20min。Boomerang封堵器组(n=178):封堵器送入动脉鞘管,展开止血伞后,调整封堵器方向后用固定夹固定,冠状动脉造影后20min拔除,经皮冠状动脉介入治疗依肝素量不同决定拔除时间,而后人工加压至出血停止。Perclose缝合器组(n=183):术后立即送入Perclose操纵杆,打结缝合穿刺点。Starclose闭合器组(n=286):冠脉造影或介入术后直接利用一个环形可弯曲的小镍钛合金闭合夹从血管外对穿刺口周围进行闭合。主要观察指标:记录每例的止血操作时间、制动总时间、血管并发症的发生和失败病例数量。结果:918例患者均进入结果分析。①Starclose闭合器组和Perclose缝合器组在缩短止血操作时间和制动时间方面明显优于Boomerang封堵器组和人工压迫止血组(P<0.01);其中Boomerang封堵器组亦较人工压迫止血组有明显缩短(P<0.01)。②采用血管闭合装置与人工压迫法相比,经皮冠状动脉介入治疗后能明显减少并发症的发生(P<0.05)。③人工压迫止血组行冠状动脉造影患者中有2例渗血,经皮冠状动脉介入治疗有12例止血失败;Boomerang封堵器组行冠状动脉造影患者中1例失败,经皮冠状动脉介入治疗有5例失败;Perclose缝合器组行冠状动脉造影患者中1例失败,经皮冠状动脉介入治疗10例失败;Starclose闭合器组行冠状动脉造影患者中1例渗血,经皮冠状动脉介入治疗5例失败。结论:3种血管闭合器包括Starclose、Perclose和Boomerang的有效性和安全性明显优于人工压迫止血,且不存在特殊生物相容性问题。Starclose闭合器的优势更为突出。

BACKGROUND： Femoral artery closure devices have been widely employed in patients undergoing coronary angiography （CAG） and percutaneous coronary intervention （PCI）. The objective evaluation and appropriate application of these closure devices need more attention. OBJECTIVE： To comparatively evaluate the safety and efficacy of manual compression and three closure devices for hemostasis at the femoral artery access site in patients undergoing CAG and PCI. DISIGN, TIME AND SERING： A randomized, grouping design and comparative observation. The patients were selected from the Department of Cardiology, General Hospital of Air Force between March 2006 and July 2008. PARTICIPANTS AND MATERIALS： A total of 918 patients undergoing CAG （n=380） or PCI （n=538）, including 562 males and 356 females aged 24 83 years, were selected. Starclose device and Perclose device were purchased from Abott, USA; Boomerang device from Cardiva, USA. METHODS： 918 patients were assigned into 4 groups according to different hemostasis methods： manual compression （MC, n=271 ）： femoral artery access site was directly compressed immediately after CAG, while at the time of activated partial thromboplastin time （APTT） was below 65s after PCI. Boomerang （n=178） group： Boomerang device was put into sheath, unclosed its umbrella to fix it up, pulled out in 20 minutes after CAG and appropriate time by the dose of heparin after PCI, followed by artificial compression till hemostasis. Perclose （n=183）： the femoral access site was sutured by Perclose joy stick to tie a knot after operation. Starclose （n=286）： Starclose utilized a small flexible nitinol clip that gave circumferential extravascular closure of the femoral arteriotomy site after CAG or PCI. MAIN OUTCOME MEASURES： Hemostasis operation time, immobilization time, total incidence rate of vascular complications and device failure cases. RESULTS： All 918 cases were included in the final analysis. （1）Patients treated with Starclose or Perclose experienced shorter operation and immobilization time to hemostasis than Boomerang and manual compression groups （P 〈 0.01 ）, while patients with Boomerang also experienced shorter time to than manual compression group （P 〈 0.01）. （2）Compared with manual compression group, device hemostasis showed lower vascular complications incidence rate after PCI （P 〈 0.05）. （3） Hemostasis failure occurred in 2/12 after CAG/PCI of manual compression patients, 1/5 of Boomerang patients, 1/10 of Perclose patients and 1/5 of Starclose patients. CONCLUSION： Three hemostasis devices （Boomerang, Perclose and Starclose） exhibit better efficacy and safety than manual compression without special problems of biocompatibility. Starclose closure device is the best choice.