摘要
目的 评估病人拔鞘管后应用经皮血管缝合器与人工压迫止血的安全性和疗效的比较。主要观察终点包括术后可下床走动时间与血管并发症。方法 10 5例病人 (男、80例 ;女 2 5例 ,平均年龄 65 .7± 12 .3岁 )在行心导管术后 ,随机分为人工压迫组 ( 组 ,5 3例 )和股动脉穿刺点经皮血管缝合器组 ( 组 ,5 2例 ) ,在术后即刻应用经皮血管缝合器和依病人抗凝水平行人工压迫止血 ,观察止血时间、下床走动时间和并发症。结果 应用经皮血管缝合器组与人工压迫组止血时间 ( 7.5± 3.0和 19.5± 6.5分 ,P<0 .0 0 1)与下床走动时间 ( 4.5± 2 .0和 16.5± 5 .0小时 ,P<0 .0 0 1)有显著缩短 ,血管并发症 (有 6人伤口渗血和血肿 >4cm, 组 7.5 % ( 4/ 5 3) , 组 3.8% ( 2 / 5 2 ) ,两组无显著差异。有 4例病人首次应用缝合器止血失效 ,因为病人的缝合血管周围病变及皮肤组织凹陷 ,有一例缝合管拆除时缝合线断接 ,首次成功率达 94% ( 48/ 5 2 ) ,失败两例再用缝合器缝合获得成功 ,总成功率达 96% ( 5 0 /5 2 )。在 组有 1例病人在血管成形术 3天后出现再次急性心肌梗死 ,给予静脉 (尿激酶 )溶栓后于穿刺伤口再出血而需压迫止血 1小时。结论 表明经皮血管缝合器应用的安全性优于人工压迫组 。
Objective To assess the safety and efficacy of suture-mediated closure device was compared with manual compression in patients after sheath removed, The major observation end points included the incidence of vascular complications and the time to ambulation after the procedures. Methods One hundred and five consecutive patients (80men,25women,mean age 65.7±12.3year ) were randomly treated with manual compression (groupⅠ, n =53)and suture-mediated percutaneous closure of antegrad femoral access site (groupⅡ, n =52) in cardiac catheterazation procedures.Suture-mediated closure or manual compression were procedure independent of the anticoagulation level after cardiac catheterazation procedures. To observe time to achieve hemostasis and time to ambulation and complications. Results A significant reduction in time to achieve hemostasis (7.5±3.0 vs 19.5±6.5 minutes, P <0.001)and time to ambulation (4.5±2.0 vs 16.5±5.0 hours, P <0.001)was associated with use of the suture-mediated closure device. The incidence of vascular complications was similar in the overall population, Hematoma>4cm and ooze of blood occurred in 6 patients, 3.8%(2/52)for groupⅡ vs 7.5%(4/53) for group Ⅰ.There were four failures to achieve hemostasis using the device due to:Inability to place the device because of peripheral vascular disease, entrapment of cutaneous tissue in the suture, A suture break that prevented hemostasis from being achieved, and avulsion of the suture from being achieved,94%(48/52) of attemp- ted uses were successful, and by using a second device in two of the fail attempts,96%(50/52)of the puncture sites were successfully closed using the device, There was one late rebleed that required 1 hr of groin clamp pressure in an angioplasty patient with AMI again after three days had received venous urokinase(groupⅠ).Conclusion The use of a suture-mediated closure device represents a safe alternative to manual compression, hemostasis and ambulation can be achieved faster with the suturing device than with manual compression, With a potential reduction in access site complications and can decrease patient discomfort.
出处
《中国心血管杂志》
2002年第6期411-412,共2页
Chinese Journal of Cardiovascular Medicine
