Beyer-Enke S A, Söldner J, Zeitler E
Department of Diagnostic and Interventional Radiology, General Hospital/North, Nuremberg, Germany.
Cardiovasc Intervent Radiol. 1996 Nov-Dec;19(6):406-10. doi: 10.1007/BF02577628.
A new hemostatic puncture closure device (HPCD) was evaluated following femoropopliteal angioplasty. Efficacy in hemostasis and complications were compared between manual compression and the new system.
One hundred patients undergoing percutaneous interventional procedures were randomly assigned to receive either manual compression or HPCD. The time to complete hemostasis (when a compression bandage was applied) was noted as well as complications such as hematoma or arterial stenosis at the puncture site. Follow-up was by clinical examination and color-coded duplex sonography (CCDS).
With the HPCD, immediate hemostasis was achieved in 22 patients (44%). Discrete oozing without the necessity of external compression or further consequences was observed in 11 patients. Mean manual compression time was 25 (+/- 20) min including application of the pressure bandage. Eleven patients needed additional manual compression and technical failures were observed in 6 patients (12%). The compression time in these 17 cases was 27 (+/- 12) min. Subcutaneous hematomata with a diameter of more than 5 cm developed in 15 of 48 patients in the HPCD group and in 14 of 48 patients in the manual compression group. No surgical or percutaneous intervention was necessary. The complication rate was comparably low in the experimental and control groups.
Compared with manual compression HPCD is faster and more accurate for sealing the arterial puncture defect following angioplasty. After an initial learning curve, it is easy to handle and time-saving as well as convenient for the patient. Furthermore, immediate and full anticoagulation is possible and arterial inflow is not compromised. A drawback is the necessity of an 8 Fr sheath. Nevertheless, the complication rate is comparably low for both methods.
对一种新型止血穿刺闭合装置（HPCD）在股腘动脉血管成形术后进行评估。比较手动压迫与新系统在止血效果及并发症方面的差异。
100例行经皮介入手术的患者被随机分配接受手动压迫或HPCD。记录完成止血的时间（即应用压迫绷带的时间）以及穿刺部位的并发症，如血肿或动脉狭窄。通过临床检查和彩色编码双功超声（CCDS）进行随访。
使用HPCD，22例患者（44%）实现了即刻止血。11例患者观察到有少量渗血，无需外部压迫或进一步处理。包括应用压力绷带在内，手动压迫的平均时间为25（±20）分钟。11例患者需要额外的手动压迫，6例患者（12%）出现技术失败。这17例患者的压迫时间为27（±12）分钟。HPCD组48例患者中有15例出现直径超过5cm的皮下血肿，手动压迫组48例患者中有14例出现。无需进行手术或经皮介入。实验组和对照组的并发症发生率相对较低。
与手动压迫相比，HPCD在血管成形术后封闭动脉穿刺缺损方面更快且更准确。经过最初的学习曲线后，它易于操作、节省时间且对患者方便。此外，可以立即进行充分抗凝且不影响动脉血流。一个缺点是需要使用8F鞘。然而，两种方法的并发症发生率都相对较低。
