新型Angio-Seal Evolution与Angio-Seal STS闭合装置的比较。

Comparison of the novel Angio-Seal Evolution with Angio-Seal STS closure device.

作者信息

Lupi Alessandro, Rognoni Andrea, Secco Gioel G, Lazzero Maurizio, Plebani Laura, Cossa Giuseppe, Reale Danilo, Sansa Mara, Bongo Angelo S, Di Mario Carlo

机构信息

Maggiore della Carità Hospital, Novara, Italy.

出版信息

Perspect Vasc Surg Endovasc Ther. 2012 Mar;24(1):28-36. doi: 10.1177/1531003512442091. Epub 2012 Apr 3.

DOI:10.1177/1531003512442091

PMID:22491159

Abstract

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.

摘要

背景

Angio-Seal Evolution（ASE）是一种新型血管闭合装置（VCD），旨在降低操作技能要求。目前尚不清楚这些改变是否能转化为更好的临床效果。

方法与结果

前瞻性评估了连续接受ASE治疗的584例患者（ASE组）和连续接受旧款Angio-Seal STS治疗的633例患者（AS-STS组）的早期VCD失败情况以及主要和次要血管并发症。早期VCD失败罕见（ASE组为1.7%，AS-STS组为1.3%，P = 0.52）。主要血管并发症风险相似（优势比[OR]=1.76，95%置信区间[CI]=0.79 - 3.90，P = 0.17），但ASE组的次要血管并发症发生率显著更高（OR = 3.36，95% CI = 1.57 - 7.21，P = 0.002）。在逻辑回归分析中，ASE是血管并发症的独立预测因素。早期VCD失败与血管并发症的最高风险相关。