Lupi Alessandro, Lazzero Maurizio, Plebani Laura, Sansa Mara, Bongo Angelo S
Department of Cardiology, Maggiore della Carità, Novara, Italy.
J Invasive Cardiol. 2011 Apr;23(4):150-5.
The Angio-Seal Evolution (ASE) is a novel vascular closure device (VCD) engineered to reduce the individual skills needed for deployment. A clinical comparison of ASE with manual femoral compression (MC) has never been reported.
A total of 451 consecutive patients treated by ASE following cardiac catheterization were compared with 451 propensity-score matched controls treated by MC. Early failure of ASE and in-hospital major vascular complications (any retroperitoneal hemorrhage, limb-threatening ischemia or surgical repair) and minor vascular complications (any groin hematoma ≥ 5 cm or pseudoaneurysm) following ASE deployment were prospectively assessed. Early failure of ASE was rare (1.8%). In the two groups, the major vascular complication rate was similar [odds ratio (OR), 2.5; 95% confidence interval (CI), 0.5-13.0; p = NS]. However, patients treated by ASE showed a significantly higher risk for minor vascular complications (OR, 2.2; 95% CI, 1.1-4.3; p = 0.029). In comparison to successful deployment, early ASE failure was associated with a very high risk for both major (OR, 15.7; 95% CI, 1.56-158.7; p = 0.002) and minor (OR, 6.1; 95% CI, 1.2-31.8; p = 0.015) vascular complications.
In a large, single-center experience, early ASE failure was rare and the rate of major vascular complications following ASE deployment was similar to controls. However, an excess of minor vascular complications (generally large groin hematomas) was observed in patients treated by ASE. Our study confirms that early ASE failure is an important risk factor for severe vascular complications.
血管封堵器Angio-Seal Evolution（ASE）是一种新型血管闭合装置（VCD），旨在减少部署所需的个人技能。尚未有关于ASE与手动股动脉压迫（MC）的临床比较报道。
将451例连续接受心脏导管插入术后接受ASE治疗的患者与451例倾向评分匹配的接受MC治疗的对照组进行比较。前瞻性评估ASE的早期失败情况以及ASE部署后住院期间的主要血管并发症（任何腹膜后出血、肢体威胁性缺血或手术修复）和次要血管并发症（任何≥5 cm的腹股沟血肿或假性动脉瘤）。ASE的早期失败很少见（1.8%）。两组的主要血管并发症发生率相似[比值比（OR），2.5；95%置信区间（CI），0.5 - 13.0；p =无显著性差异]。然而，接受ASE治疗的患者出现次要血管并发症的风险显著更高（OR，2.2；95% CI，1.1 - 4.3；p = 0.029）。与成功部署相比，ASE早期失败与主要（OR，15.7；95% CI，1.56 - 158.7；p = 0.002）和次要（OR，6.1；95% CI，1.2 - 31.8；p = 0.015）血管并发症的极高风险相关。
在一项大型单中心研究中，ASE早期失败很少见，ASE部署后的主要血管并发症发生率与对照组相似。然而，在接受ASE治疗的患者中观察到次要血管并发症（通常为大型腹股沟血肿）过多。我们的研究证实，ASE早期失败是严重血管并发症的重要危险因素。
