Wagner Steven C, Gonsalves Carin F, Eschelman David J, Sullivan Kevin L, Bonn Joseph
Division of Cardiovascular and Interventional Radiology, Thomas Jefferson University Hospital, Gibbon Building, Suite 4200, 111 South 11th Street, Philadelphia, Pennsylvania 19107, USA.
J Vasc Interv Radiol. 2003 Jun;14(6):735-41. doi: 10.1097/01.rvi.0000079982.80153.d9.
To evaluate the incidence and types of complications encountered with use of a percutaneous suture-mediated closure device versus manual compression for arteriotomy closure in a retrospective case-controlled study.
The authors identified 100 consecutive patients, 15 men and 85 women 21-85 years of age (mean, 50 years), between December 2000 and July 2001 in whom the Closer percutaneous suture-mediated closure device was used during 65 uterine artery embolization (UAE) procedures, 11 hepatic chemoembolization procedures, nine diagnostic angiography procedures, seven peripheral vascular interventions, six visceral arterial interventions, and two thrombolysis procedures. An age-, sex-, and procedure-matched control population was identified in which manual compression was performed. Procedure reports and clinical charts were reviewed for the presence of puncture-site complications, as categorized according to Society of Interventional Radiology reporting standards, and for risk factors and comorbid conditions (hypertension, diabetes, stroke, smoking, and coronary artery disease). Follow-up visits and imaging studies were reviewed for patients with complications.
In the Closer group, there were seven device failures, four minor complications, and three major complications. Minor complications included two groin hematomas and two cases of persistent pain at the arteriotomy site. Three major complications consisted of two cases of external iliac artery dissection, one with distal embolization, and one case of common femoral artery (CFA) occlusion and distal embolization. All major complications occurred in women undergoing UAE. One patient required thromboendarterectomy and patch angioplasty to repair the CFA occlusion, as well as amputation of a gangrenous toe. In the manual-compression group, there was one minor complication (a groin hematoma) and no major complications. There were significantly more complications in the Closer group than in the manual compression group (P =.02).
Significantly more complications were associated with use of a percutaneous suture-mediated closure device than with manual compression for arteriotomy-site hemostasis. Major complications and associated morbidity may be seen with use of percutaneous suture-mediated closure devices. In particular, an unexpectedly high frequency of device-related complications was demonstrated in young women undergoing UAE.
在一项回顾性病例对照研究中，评估使用经皮缝线介导闭合装置与手动压迫法进行动脉切开术闭合时所遇到并发症的发生率及类型。
作者纳入了2000年12月至2001年7月期间连续的100例患者，年龄21 - 85岁（平均50岁），其中男性15例，女性85例。在65例子宫动脉栓塞（UAE）手术、11例肝动脉化疗栓塞手术、9例诊断性血管造影手术、7例外周血管介入手术、6例内脏动脉介入手术及2例溶栓手术中使用了Closer经皮缝线介导闭合装置。确定了一个年龄、性别和手术相匹配的对照组，采用手动压迫法。查阅手术报告和临床病历，以确定是否存在穿刺部位并发症（根据介入放射学会报告标准分类）以及危险因素和合并症（高血压、糖尿病、中风、吸烟和冠状动脉疾病）。对有并发症的患者进行随访和影像学检查。
在Closer组中，有7例装置失败、4例轻微并发症和3例严重并发症。轻微并发症包括2例腹股沟血肿和2例动脉切开部位持续疼痛。3例严重并发症包括2例髂外动脉夹层，其中1例伴有远端栓塞，1例股总动脉（CFA）闭塞并伴有远端栓塞。所有严重并发症均发生在接受UAE的女性患者中。1例患者需要进行血栓内膜切除术和补片血管成形术来修复CFA闭塞，以及截肢坏死的脚趾。在手动压迫组中，有1例轻微并发症（腹股沟血肿），无严重并发症。Closer组的并发症明显多于手动压迫组（P = 0.02）。
与手动压迫动脉切开部位止血相比，使用经皮缝线介导闭合装置相关的并发症明显更多。使用经皮缝线介导闭合装置可能会出现严重并发症及相关发病率。特别是，在接受UAE的年轻女性中，与装置相关的并发症发生率出乎意料地高。
