Comparison of the novel Angio-Seal Evolution with Angio-Seal STS closure device.
Comparison of the novel Angio-Seal Evolution with Angio-Seal STS closure device.
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DOI：
10.1177/1531003512442091
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发表时间：
2012-03-01
期刊：
影响因子：
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通讯作者：
Di Mario, Carlo
中科院分区：
文献类型：
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作者：
Lupi, Alessandro;Rognoni, Andrea;Di Mario, Carlo
背景：Angio-Seal Evolution (ASE) 是一种新型血管闭合装置 (VCD)，旨在减少部署技能。目前尚不清楚这些变化是否会转化为更好的临床结果。 方法和结果：对 584 名连续接受 ASE 治疗的患者（ASE 组）和 633 名连续接受旧式 Angio-Seal STS 治疗的患者（AS-STS 组）进行了前瞻性评估。早期 VCD 失败很少见（ASE 1.7% vs AS-STS 1.3%，P = .52）。主要血管并发症风险相似（比值比 [OR] = 1.76，95% 置信区间 [CI] = 0.79-3.90，P = .17），但 ASE 组的次要血管并发症发生率显着较高（OR = 3.36，95% CI = 1.57-7.21，P = .002）。在逻辑回归中，ASE 是血管并发症的独立预测因子。早期 VCD 失败与血管并发症的最高风险相关。结论：在大量未经选择的人群中，接受 ASE 治疗的患者出现轻微血管并发症的风险增加。早期 VCD 失败会对短期血管预后产生负面影响。
BACKGROUND: Angio-Seal Evolution (ASE) is a novel vascular closure device (VCD) engineered to reduce deployment skills. It is unknown if these changes translated into better clinical results.METHODS AND RESULTS: Early VCD failure and major and minor vascular complications were prospectively assessed in 584 consecutive patients treated by ASE (ASE group) and in 633 consecutive patients treated by the older Angio-Seal STS (AS-STS group). Early VCD failure was rare (ASE 1.7% vs AS-STS 1.3%, P = .52). Major vascular complication risk was similar (odds ratio [OR] = 1.76, 95% confidence interval [CI] = 0.79-3.90, P = .17), but minor vascular complication rate was significantly higher in the ASE group (OR = 3.36, 95% CI = 1.57-7.21, P = .002). At logistic regression ASE was an independent predictor of vascular complications. Early VCD failure was associated with the highest risk for vascular complications.CONCLUSIONS: In a large unselected population, ASE-treated patients showed increased risk for minor vascular complications. Early VCD failure negatively affected short-term vascular prognosis.