ExoSeal^(TM)血管封堵器在逆行经股动脉介入诊疗中的应用

Clinical application of ExoSeal^(TM)vascular closure device in interventional management via retrograde femoral artery access

目的探讨血管封堵器ExoSeal^(TM)在逆行经股动脉介入诊疗中对穿刺点快速止血的安全性及有效性。方法回顾性分析2016年3月至2016年4月收治的124例逆行经股动脉介入诊疗患者临床资料。诊疗术中分别采用ExoSeal^(TM)封堵器(n=52)和人工压迫(n=72)方法对股动脉穿刺点止血。记录并比较两组患者即刻止血时间、徒手压迫时间、制动时间、压迫过程出血量及操作后相关并发症。结果ExoSeal^(TM)封堵组技术成功率为98.1%(51/52)。ExoSeal^(TM)封堵组、人工压迫组即刻止血时间分别为(0.28±0.08)min、(5.83±1.46)min,徒手压迫时间分别为(2.65±0.57)min、(7.70±1.88)min,制动时间分别为(2.72±0.43)h、(6.15±0.69)h,差异均有显著统计学意义(P<0.01)。ExoSeal^(TM)封堵组发生皮下血肿1例,人工压迫组出现皮下血肿3例,假性动脉瘤1例,并发症发生率分别为1.92%(1/52)、5.56%(4/72),差异无统计学意义(P>0.05)。人工压迫组压迫过程出血量为(1.11±0.86)ml,明显低于ExoSeal^(TM)封堵组(7.83±2.08)ml,差异有显著统计学意义(P<0.01)。结论逆行经股动脉介入术中采用Exo Seal TM封堵器对股动脉穿刺点止血,安全有效。

Objective To discuss the safety and efficacy of using ExoSealTM vascular closure device to obtain rapid hemostasis of puncture site in interventional procedure via retrograde femoral artery access. Methods The clinical data of 124 patients, who were admitted to authors＇ hospital during the period from March 2016 to April 2016 to receive interventional procedure via retrograde femoral artery access, were retrospectively analyzed. During the performance of intervention, ExoSealTM vascular closure device （ExoSealTM group, n=52） or manual compression （MC group, n=72） was employed to make femoral artery puncture point hemostasis. The time spent for hemostasis, the manual compression time, the limb immobilization time, the amount of blood loss during compression process, and the procedure-related complications were recorded and the results were compared between the two groups. Results Technical success rate in ExoSealTM group was 98.1%（51/52）. In ExoSealTM group and MC group, the time spent for hemostasis was （0.28±0.08） rain and （5.83±1.46） min respectively, the manual compression time was （2.65±0.57） rain and （7.70±1.88） rain respectively, the limb immobilization time was （2.72±0.43） h and （6.15±0.69） h respectively; all the differences between the two groups were statistically significant （P〈0.01）. In ExoSealTM group subcutaneous hemotoma occurred in one patient, while in MC group subcutaneous hemotoma occurred in 3 patients and pseudoaneurysm in one patient; the complication rates were 1.92% （1/52） and 5.56% （4/72） respectively, but the difference was not statistically significant （P〉0.05）. In MC group the amount of blood loss during compression process was （1.11±0.86） ml, which was remarkably less than （7.83±2.08） ml in ExoSealTM group, the difference between the two groups was statistically significant （P〈0.01）. Conclusion For hemostasis of puncture site in interventional management via retrograde femoral artery access, the use of ExoSealTM vascular closure device is safe and effective.（J Intervent Radiol, 2017, 26： 547-550）