Department of Radiology, Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, WA 6009, Australia.
J Endovasc Ther. 2010 Feb;17(1):46-50. doi: 10.1583/09-2873.1.
To evaluate the StarClose device and compare its success rates in antegrade and retrograde puncture closures.
A retrospective review of all StarClose deployments from April 2005 to July 2007 was performed in a single tertiary referral institution radiology department. In this time period, 143 StarClose devices were deployed in 132 patients (102 men; mean age 68+/-14 years). Of these, 40 (28%) were deployed after antegrade and 103 (72%) after retrograde common femoral arterial punctures. Hospital notes were reviewed to evaluate minor (managed conservatively with compression) and major (requiring surgical intervention) complication rates in the immediate postprocedure period and the following 24 hours. Late complications were also assessed.
There were 11 (7.7%) immediate failures of device deployment: 4/40 (10.0%) antegrade and 7/103 (6.8%) retrograde. Within these 11 punctures, 1 major complication occurred that required surgical retrieval of the device following a retrograde puncture. No other major and 12 (9.1%) minor complications occurred following the 132 successful StarClose deployments. No late complications were seen on clinical or radiological follow-up. The total major complication rate was 0.7% (1/143). The total minor complication rate was 15.4% (22/143): 9/40 (22.5%) following antegrade punctures and 13/103 (12.6%) following retrograde punctures.
The StarClose device is associated with a low major complication rate. A higher rate of minor complications was observed following antegrade punctures but all were managed with simple compression. Prospective randomized trials comparing closure devices are needed to evaluate their relative efficacy and safety in antegrade and retrograde punctures.
评估 StarClose 装置，并比较其顺行和逆行穿刺闭合的成功率。
对 2005 年 4 月至 2007 年 7 月期间在一家三级转诊机构放射科进行的所有 StarClose 部署进行回顾性分析。在此期间，对 132 名患者（102 名男性；平均年龄 68+/-14 岁）中的 143 个 StarClose 装置进行了部署。其中，40 个（28%）为顺行穿刺，103 个（72%）为逆行股总动脉穿刺。查阅医院记录，评估即刻（用压迫法保守处理）和 24 小时内主要（需要手术干预）并发症的发生率。同时评估迟发性并发症。
有 11 个（7.7%）装置部署即时失败：4/40（10.0%）顺行，7/103（6.8%）逆行。在这 11 个穿刺点中，有 1 例逆行穿刺后发生严重并发症，需要手术取出装置。在 132 例成功的 StarClose 部署中，没有发生其他严重和 12 例（9.1%）轻微并发症。临床或影像学随访未见迟发性并发症。总主要并发症发生率为 0.7%（1/143）。总轻微并发症发生率为 15.4%（22/143）：40 个穿刺点中有 9 个（22.5%），103 个穿刺点中有 13 个（12.6%）。
StarClose 装置主要并发症发生率较低。顺行穿刺后观察到轻微并发症发生率较高，但均采用简单压迫处理。需要前瞻性随机试验来比较封堵装置在顺行和逆行穿刺中的相对疗效和安全性。
