经皮缝合装置在经皮冠状动脉介入术中的应用价值

The clinical application of Perclose in percutaneous coronary intervention

目的评价经皮缝合装置(Percloser缝合器)止血的安全性、有效性及临床应用价值。方法选取2002年4月～2005年3月所做的经皮冠状动脉介入治疗患者504例。按止血方法不同分为传统压迫止血组254例和血管缝合组250例,分析两组在止血时间、制动时间、总卧床时间及各种并发症的差异。结果缝合法与压迫法比较,止血时间:压迫组为(25±6)分钟,血管缝合组为:(6.0±0.4)分钟(P<0.001):下肢制动时间:压迫组为(26±4)小时,血管缝合组为(4.0±1.2)小时(P<0.001);总卧床时间:压迫组为(25.2±4.5)小时,血管缝合组(6.0±1_3)小时(P<0.001)。压迫组术后并发症如出血、血肿、迟发出血(第3日-1周)、迷走反射、皮肤溃烂等,明显高于缝合组(P<0.001)。结论Percloser缝合器止血用于冠状动脉造影及经皮腔内冠状动脉成形术或支架术后患者,止血时间与卧床制动时间明显缩短,并发症少,安全有效,操作简便,止血效果可靠。

Objectives To assess the validity efficacy and clinical application of a suture-mediated closure device(Percloser) compared with standard manual compression in patients after percutaneous coronary interventions. The major observation end points included the incidence of vascular complications and the time to ambulation after the procedures. Methods Five hundred and four consecutive patients underwent percutaneous coronary intervention were randomly treated with standard manual compression (n=254) and suture-mediated percutaneous closure of antegrade femoral access site by Percloser (n=250)in cardiac catheterizations procedures. Suturemediated closure or manual compression were procedured independent of the anticoagulation level after cardiac catheterization procedures. The time to achieve hemostasis and the time to ambulation was compared,and the incidence of complications was evaluated too. Results A significant reduction in the time to achieve hemostasis was observed (6±0.4 vs 25±5.6 minutes,P<0.001) in percloser closure group and standard compression group respectively. The time to ambulation was also lessened (4±1.2 vs 26±3.8 hours P<0.001) in the two groups and this seemed to be significantly associated with use of the suture-mediated closure device (Perclose).There was a great decrease of general bedrest time in percloser use group compared with manual compression group (6.0±1.3 vs 25.2±4.5 h, P<0.001).The incidence of vascular complications was higher in the standard compression group, in which 6% (15/254) cases of hematoma and 19% (48/254) cases of blood ooze was observed. There were five failures to achieve hemostasis using the device, two cases was due to over stress and rupture of the suture, another case was unable to place the device because of peripheral vascular disease and it caused over bleeding. The former two failed attempts of the puncture were successfully closed by using a second device. The later was saved by carefully manual looping. Conclusions The use of a suture-mediated closure device represents a safe alternative to manual compression and it was simple, effective and easy to use. The comparison confirmed that the time of hemostasis and the time of ambulation can be greatly shortened with the use of Percloser suturing device compared with the manual compression. It was observed that Perclose could potentially reduce arterial access site complications and greatly lessen patient's discomfort comparing with traditional standard manual compression.