国人冠状动脉造影及介入治疗后血管封堵器的临床应用

Systematic Use of a Angio-Seal Immediately After Coronary Angiography and Percutaneous Coronary Intervention in Chineses

目的 :观察和评估国人在冠状动脉造影和经皮冠状动脉介入治疗 (PCI)后即刻在股动脉穿刺处使用血管封堵器的安全性和并发症发生率。方法 :3 0 5例符合入选标准并接受封堵器治疗的患者 ,男性 2 2 9例 ,女性 76例。其中仅接受冠状动脉造影者 (诊断组 ) 161例 ,而接受PCI者 (PCI组 ) 14 4例 ,所有患者术前均给予口服阿司匹林≥ 10 0mg/d及氯吡格雷 75mg/d。通过采用经股动脉途径的Judkins技术完成冠状动脉造影及PCI术。主要安全终点为住院期间严重并发症的发生率 ,包括 :任何需要血管外科治疗 ,外周动脉的PCI或需超声引导的加压如假性动脉瘤 ,需输血的严重出血 ,腹膜后血肿 ,血栓形成或远端脉搏消失 ,腹股沟感染 ,明显腹股沟血肿 ,死亡。结果 :①诊断组及PCI组 ,成功放置封堵器分别为 98 8%和 98 6% (P >0 0 5 ) ,即刻止血分别为 96 9%和 94 4% ,无显著性差异 (P >0 0 5 )。封堵器放置失败的所有患者经手工压迫和压力绷带包扎均成功止血。诊断组 7例 ,PCI组 8例( 4 4%vs 5 6% ,P >0 0 5 )必须经压力绷带包扎方能完全止血 ;② 3例出现严重并发症 ( 0 98% ) ,诊断组 1例 ,PCI组 2例 ,其中 1例死亡。两组间并发症发生率无显著差异 (诊断组 0 6% ,PCI组 1 4% ,P >0 0 5 )。结论 :在诊断性造影和PCI后 ,?

Objective: To evaluate the safety and comlication rates of Angio-Seal closure device for systematic sealing of femoral access sites immediately after diagnostic coronary angiography and Percutaneous Coronary Intervention.Methods:Three hundreds five patients met the inclusion criteria and were treated with the Angio-Seal.A total of 161 patients underwent diagnostic coronary angiography and 144 patients underwent percutaneous coronary intervention. All patients received oral aspirin≥100 mg/d or clopidogrel 75 mg/d. In all patients, the Judkins technique via the femoral artery was used. Immediately after the procedure,the arterial sheath was removed and the closure device was deployed. The primary safety endpoint was the incidence of major complications during the in-hospital period,including any vascular surgery,major bleeding requiring transfusions,retroperitoneal hematoma,thrombosis or loss of distal pulses,groin infections,significant groin hematoma,and death .Results: Deployment success rates of the Angio-Seal were comparable for patients undergoing diagnostic vs. interventional procedures (98.8% vs 98.6%,p >0.05). Complete hemostasis immediately after deployment of the device was achieved in >90% of all patients,in diagnostic and the interventional groups were 96.9% and 94.4%,respectively ( p >0.05). Major complications were observed in 0.98% of all patients,with no differences between diagnositic and interventional patients (0.6% vs 1.4%,p >0.05).Conclusions: Systematic sealing of femoral access sites after both diagnostic and interventional procedures allows for immediate sheath removal with reliable hemostasis. The use of a collagen-based closure device is associated with a low rate of clinically significant complications.