Alessandro Lupi, Andrea Rognoni, Gioel G Secco, Maurizio Lazzero, Laura Plebani, Giuseppe Cossa, Danilo Reale, Mara Sansa, Angelo S Bongo, Carlo Di Mario
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引用次数: 3
摘要
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转化为更好的临床结果。方法和结果:对584例连续接受ASE治疗的患者(ASE组)和633例连续接受老年Angio-Seal STS治疗的患者(AS-STS组)进行早期VCD衰竭和主要和次要血管并发症的前瞻性评估。早期VCD失败很少见(ASE 1.7% vs AS-STS 1.3%， P = 0.52)。主要血管并发症发生率相似(优势比[OR] = 1.76, 95%可信区间[CI] = 0.79 ~ 3.90, P = 0.17)，但ASE组的次要血管并发症发生率明显高于对照组(OR = 3.36, 95% CI = 1.57 ~ 7.21, P = 0.002)。在逻辑回归中，ASE是血管并发症的独立预测因子。早期VCD衰竭与血管并发症的最高风险相关。结论:在大量未选择的人群中，ase治疗的患者出现轻微血管并发症的风险增加。早期VCD衰竭对短期血管预后有负面影响。
Comparison of the novel Angio-Seal Evolution with Angio-Seal STS closure device.
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.
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