冠状动脉介入术后应用新型血管闭合器Boomerang~的初步研究

Preliminary study on application of a new vascular closure device Boomerang~ in patients after percutaneous coronary intervention

目的评价冠状动脉造影或经皮冠状动脉介入治疗(PCI)后,应用新型血管闭合器Boomerang的有效性及安全性。方法入选2005年2月至2007年3月在北京军区总医心血管内科进行冠状动脉造影或PCI的112例患者,随机应用血管闭合器Boomerang(Boomerang组,68例)和Angioseal(Angioseal组,44例)对股动脉穿刺部位进行封闭止血,观察两组止血时间、下肢制动时间,术后即刻、术后4h、出院前24h内出血发生率。结果两组即刻闭合成功率均较高(94%vs91%,P=0.78),两组止血时间〔(1.89±1.23)minvs(2.01±1.21)min,P=0.63〕、下肢制动时间〔(5.76±2.23)hvs(5.01±2.05)h,P=0.54〕、术后即刻(16%vs15%,P=0.86)和出院前24h内(1%vs3%,P=0.75)的小出血发生率等均无显著性差异,但术后4h Boomerang组小出血发生率明显低于Angi-oseal组(7%vs13%,P=0.04),两组均无大出血发生。与合并高血压、高脂血症的患者比较,有糖尿病和吸烟史的患者术后即刻、术后4h和出院前24h内小出血发生率均显著增加(P<0.05)。结论新型血管闭合器Boomerang闭合股动脉穿刺口有效、安全,但对于有糖尿病和吸烟史的患者应谨慎选择。

Objective To examine the efficacy and safety of a new vascular closure device Boomerang in patients after coronary angiography and percutaneous coronary intervention（PCI）. Methods A total of 112 consecutive patients who received coronary angiography or PCI between Feb 2005-March 2007 at the Department of Cardiology in General Hospital of Beijing Military Region were randomly divided into Boomerang group（n = 68）and Angioseal group（n= 44） based on closure of femoral artery with Boomerang or Angioseal. The hemostasis time, leg immobilization time and incidence rates of hemorrhage immediately and 4h after operation and 24h before discharge were observed. Results The success rate of closure was high in both groups（94% vs 91% ,P=0.78）. The hemostasis time [（1.89±1.23）min vs （2.01±1.21）rain,P=0.63], the leg immobilization time [（5.76±2.23）h vs （5. 01±2.05）h, P= 0.54] and the incidence rates of mini-hemorrhage immediately after operation（16 % vs 15 %, P= 0.86） and 24h before discharge（1% vs 3 %, P= 0.75） were not significantly different, but the mini-hemorrhage incidence rates after 4h were significantly lower in Boomerang group than in Angioseal group （7% vs 13 %, P= 0.04）. No hemorrhea was seen in both groups. There were higher incidence rates of mini-hemorrhage immediately and 4h after operation and 24h before discharge in patients with diabetes mellitus and history of smoking as compared with those complicated with hypertension and hyperlipemia（P〈0.05）. Conclusion The vascular closure device Boomerang is effective and safe in patients after coronary angiography and PCI, but it should be used carefully in patients complicated with diabetes mellitus and history of smoking.