Park Yulri, Roh Hong Gee, Choo Sung Wook, Lee Sung Hoon, Shin Sung Wook, Do Young Soo, Byun Hong Sik, Park Kwang Bo, Jeon Pyoung
Department of Radiology and Center for Imaging Science, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Korean J Radiol. 2005 Oct-Dec;6(4):248-55. doi: 10.3348/kjr.2005.6.4.248.
Rapid and effective hemostasis at femoral puncture sites minimizes both the hospital stay and patient discomfort. Therefore, a variety of arterial closure devices have been developed to facilitate the closure of femoral arteriotomy. The objective of this prospective study was to compare the efficacy of two different closure devices; a collagen plug device (Angio-Seal) and a suture-mediated closure device (the Closer S).
From March 28, 2003 to August 31, 2004, we conducted a prospective study in which 1,676 cases of 1,180 patients were treated with two different types of closure device. Angio-Seal was used in 961 cases and the Closer S in 715 cases. The efficacy of the closure devices was assessed, as well as complications occurring at the puncture sites.
Successful immediate hemostasis was achieved in 95.2% of the cases treated with Angio-Seal, and in 89.5% of the cases treated with the Closer S (p < 0.05). The rates of minor and major complications occurring between the two groups were not significantly different. In the Closer S group, we observed four major complications (0.6%), that consisted of one massive retroperitoneal hemorrhage (surgically explored) and three pseudoaneurysms. In the Angio-Seal group, we observed three major complications (0.3%) that consisted of one femoral artery occlusion, one case of infection treated with intravenous antibiotics and one pseudoaneurysm.
The use of Angio-Seal was found to be more effective than that of the Closer S with regard to the immediate hemostasis of the femoral puncture sites. However, we detected no significant differences in the rate at which complications occurred.
在股动脉穿刺部位实现快速有效的止血，可使住院时间和患者不适程度降至最低。因此，已研发出多种动脉闭合装置，以促进股动脉切开术的闭合。本前瞻性研究的目的是比较两种不同闭合装置的疗效；一种是胶原塞装置（血管封堵器）和一种缝线介导闭合装置（Closure S）。
从2003年3月28日至2004年8月31日，我们进行了一项前瞻性研究，其中1180例患者的1676例接受了两种不同类型的闭合装置治疗。血管封堵器用于961例，Closure S用于715例。评估了闭合装置的疗效以及穿刺部位出现的并发症。
使用血管封堵器治疗的病例中，95.2%实现了即时成功止血，使用Closure S治疗的病例中，89.5%实现了即时成功止血（p<0.05）。两组之间发生的轻微和严重并发症发生率无显著差异。在Closure S组中，我们观察到4例严重并发症（0.6%），包括1例大量腹膜后出血（进行了手术探查）和3例假性动脉瘤。在血管封堵器组中，我们观察到3例严重并发症（0.3%），包括1例股动脉闭塞、1例经静脉抗生素治疗的感染病例和1例假性动脉瘤。
在股动脉穿刺部位的即时止血方面，发现使用血管封堵器比使用Closure S更有效。然而，我们未检测到并发症发生率的显著差异。
