Ratnam Lakshmi A, Raja Jowad, Munneke Graham J, Morgan Robert A, Belli Anna-Maria
Department of Radiology, St. George's Hospital, Blackshaw Road, London, SW17 0QT, UK.
Cardiovasc Intervent Radiol. 2007 Mar-Apr;30(2):182-8. doi: 10.1007/s00270-006-0226-1.
We compared the use of manual compression and Angio-Seal and Starclose arterial closure devices to achieve hemostasis following common femoral artery (CFA) punctures in order to evaluate safety and efficacy. A prospective nonrandomized, single-center study was carried out on all patients undergoing CFA punctures over 1 year. Hemostasis was achieved using manual compression in 108 cases, Angio-Seal in 167 cases, and Starclose in 151 cases. Device-failure rates were low and not significantly different in the two groups (manual compression and closure devices; p = 0.8). There were significantly more Starclose (11.9%) patients compared to Angio-Seal (2.4%), with successful initial deployment subsequently requiring additional manual compression to achieve hemostasis (p < 0.0001). A significant number of very thin patients failed to achieve hemostasis (p = 0.014). Major complications were seen in 2.9% of Angio-Seal, 1.9% of Starclose, and 3.7% of manual compression patients, with no significant difference demonstrated; 4.7% of the major complications were seen in female patients compared to 1.3% in males (p = 0.0415). All three methods showed comparable safety and efficacy. Very thin patients are more likely to have failed hemostasis with the Starclose device, although this did not translate into an increased complication rate. There is a significant increased risk of major puncture-site complications in women with peripheral vascular disease.
我们比较了手动压迫与使用Angio-Seal和Starclose动脉闭合装置在股总动脉（CFA）穿刺后实现止血的情况，以评估其安全性和有效性。对1年内所有接受CFA穿刺的患者进行了一项前瞻性非随机单中心研究。108例患者采用手动压迫止血，167例使用Angio-Seal，151例使用Starclose。两组（手动压迫和闭合装置）的装置故障率较低且无显著差异（p = 0.8）。与Angio-Seal组（2.4%）相比，Starclose组患者（11.9%）中，成功初始部署后需要额外手动压迫以实现止血的情况显著更多（p < 0.0001）。相当数量的极瘦患者未能实现止血（p = 0.014）。Angio-Seal组2.9%、Starclose组1.9%、手动压迫组3.7%的患者出现了主要并发症，差异无统计学意义；女性患者中4.7%出现主要并发症，男性患者为1.3%（p = 0.0415）。所有三种方法显示出相当的安全性和有效性。极瘦患者使用Starclose装置时更有可能止血失败，尽管这并未转化为更高的并发症发生率。外周血管疾病女性患者发生主要穿刺部位并发症的风险显著增加。
