血管闭合装置在当代实践中的失败。
Vascular closure device failure in contemporary practice.
机构信息
Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA.
出版信息
JACC Cardiovasc Interv. 2012 Aug;5(8):837-44. doi: 10.1016/j.jcin.2012.05.005.
OBJECTIVES
The goal of this study was to assess the frequency and predictors of vascular closure device (VCD) deployment failure, and its association with vascular complications of 3 commonly used VCDs.
BACKGROUND
VCDs are commonly used following percutaneous coronary intervention on the basis of studies demonstrating reduced time to ambulation, increased patient comfort, and possible reduction in vascular complications as compared with manual compression. However, limited data are available on the frequency and predictors of VCD failure, and the association of deployment failure with vascular complications.
METHODS
From a de-identified dataset provided by Massachusetts Department of Health, 23,813 consecutive interventional coronary procedures that used either a collagen plug-based (n = 18,533), a nitinol clip-based (n = 2,284), or a suture-based (n = 2,996) VCD between June 2005 and December 2007 were identified. The authors defined VCD failure as unsuccessful deployment or failure to achieve immediate access site hemostasis.
RESULTS
Among 23,813 procedures, the VCD failed in 781 (3.3%) procedures (2.1% of collagen plug-based, 6.1% of suture-based, 9.5% of nitinol clip-based VCDs). Patients with VCD failure had an excess risk of "any" (7.7% vs. 2.8%; p < 0.001), major (3.3% vs. 0.8%; p < 0.001), or minor (5.8% vs. 2.1%; p < 0.001) vascular complications compared with successful VCD deployment. In a propensity score-adjusted analysis, when compared with collagen plug-based VCD (reference odds ratio [OR] = 1.0), nitinol clip-based VCD had 2-fold increased risk (OR: 2.0, 95% confidence interval [CI]: 1.8 to 2.3, p < 0.001) and suture-based VCD had 1.25-fold increased risk (OR: 1.25, 95% CI: 1.2 to 1.3, p < 0.001) for VCD failure. VCD failure was a significant predictor of subsequent vascular complications for both collagen plug-based VCD and nitinol clip-based VCD, but not for suture-based VCD.
CONCLUSIONS
VCD failure rates vary depending upon the type of VCD used and are associated with significantly higher vascular complications as compared with deployment successes.
目的
本研究旨在评估血管闭合装置（VCD）置入失败的频率和预测因素，以及其与 3 种常用 VCD 的血管并发症之间的关联。
背景
基于研究显示与手动压迫相比，VCD 可缩短下床活动时间、增加患者舒适度并可能降低血管并发症的优势，VCD 已广泛应用于经皮冠状动脉介入治疗。然而，关于 VCD 失败的频率和预测因素，以及与 VCD 失败相关的血管并发症的数据有限。
方法
从马萨诸塞州卫生部提供的一个去标识数据集，作者确定了 2005 年 6 月至 2007 年 12 月期间使用胶原塞（n=18533）、镍钛诺夹（n=2284）或缝线（n=2996）VCD 的 23813 例连续介入性冠状动脉手术。作者将 VCD 失败定义为未能成功置入或未能立即实现血管穿刺部位止血。
结果
在 23813 例手术中，781 例（3.3%）手术中 VCD 失败（胶原塞 2.1%，缝线 9.5%，镍钛诺夹 6.1%）。与 VCD 成功置入相比，VCD 失败患者发生“任何”（7.7%比 2.8%；p<0.001）、主要（3.3%比 0.8%；p<0.001）或次要（5.8%比 2.1%；p<0.001）血管并发症的风险更高。在倾向评分调整分析中，与胶原塞 VCD 相比（参考比值比[OR] = 1.0），镍钛诺夹 VCD 的风险增加 2 倍（OR：2.0，95%置信区间[CI]：1.8 至 2.3，p<0.001），缝线 VCD 的风险增加 1.25 倍（OR：1.25，95%CI：1.2 至 1.3，p<0.001）。VCD 失败是胶原塞 VCD 和镍钛诺夹 VCD 发生血管并发症的显著预测因素，但缝线 VCD 并非如此。
结论
VCD 失败的发生率因所使用的 VCD 类型而异，与 VCD 成功置入相比，VCD 失败与显著更高的血管并发症相关。
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