Kälsch H I M, Eggebrecht H, Mayringer S, Konorza T, Sievers B, Sack S, Erbel R, Kroeger K
Department of Cardiology, West-German Heart Center, Hufelandstr. 55, 45122, Essen, Germany.
Clin Res Cardiol. 2008 Jan;97(1):43-8. doi: 10.1007/s00392-007-0575-z. Epub 2007 Sep 18.
Vascular closure devices (VCD) are well established to facilitate hemostasis after cardiac catheterization procedures. However, impairment of flow due to the reduction of femoral artery diameter remains a major concern. The present study aims to evaluate leg perfusion before and after application of collagen- and suture-based vascular closure devices.
A total of 366 patients (age: 64.3 years+/-10.7, male: 71.3%) were randomized to receive femoral access site closure with either a collagen-based closure device (group A) (n=214) or a suture-mediated device (group B) (n=152), immediately following coronary catheterization procedures. In all patients, the ankle-brachial-index (ABI) was measured before and the day after closure device application.
In group A, mean ABI at baseline was 1.09+/-0.2, in group B 1.11+/-0.2. In both groups, there was a significant, albeit clinically not relevant, reduction in post-procedural ABI (group A: 1.04+/-0.2, p<0.01 vs baseline, group B: 1.06+/-0.2, p<0.01 vs baseline). DeltaABI was not different between both VCD groups (p=0.55). In patients with peripheral vascular disease (PVD), neither the Angioseal device (mean ABI at baseline 0.76+/-0.1) nor the Perclose-device (mean ABI at baseline 0.79+/-0.1) induced a remarkable impairment of leg perfusion (Angioseal: 0.77+/-0.1, p=0.9 vs baseline, Perclose: 0.78+/-0.1, p=1.0 vs baseline). Clinically, no aggravation of claudication was observed in the PVD patient group.
Both vascular closure devices are not associated with clinically relevant reduction in ABI. There was no difference between the two groups with respect to the level of flow impairment. Both devices may be safely used in patients with reduced ABI.
血管闭合装置（VCD）已被广泛应用于心脏导管插入术后促进止血。然而，股动脉直径减小导致的血流受损仍是一个主要问题。本研究旨在评估应用基于胶原蛋白和缝线的血管闭合装置前后的下肢灌注情况。
总共366例患者（年龄：64.3岁±10.7岁，男性：71.3%）在冠状动脉导管插入术后立即被随机分组，分别接受基于胶原蛋白的闭合装置（A组）（n = 214）或缝线介导装置（B组）（n = 152）进行股动脉穿刺部位闭合。在所有患者中，于闭合装置应用前及应用后一天测量踝肱指数（ABI）。
A组基线时平均ABI为1.09±0.2，B组为1.11±0.2。两组术后ABI均有显著降低，尽管在临床上无相关性（A组：1.04±0.2，与基线相比p < 0.01；B组：1.06±0.2，与基线相比p < 0.01）。两种VCD组间的ΔABI无差异（p = 0.55）。在患有外周血管疾病（PVD）的患者中，Angioseal装置（基线时平均ABI为0.76±0.1）和Perclose装置（基线时平均ABI为0.79±0.1）均未引起下肢灌注的显著受损（Angioseal：0.77±0.1，与基线相比p = 0.9；Perclose：0.78±0.1，与基线相比p = 1.0）。临床上，PVD患者组未观察到跛行加重。
两种血管闭合装置均未导致临床上与ABI相关的降低。两组在血流受损程度方面无差异。两种装置均可安全用于ABI降低的患者。
