Kara Kaffer, Mahabadi Amir A, Rothe Hanna, Müller Patrick, Krüger Jan, Neubauer Horst, Klein-Wiele Oliver, Mügge Andreas, Kahlert Philipp, Erbel Raimund
1 Cardiovascular Center, St. Josef Hospital, Ruhr-University Bochum, Germany.
J Endovasc Ther. 2014 Dec;21(6):822-8. doi: 10.1583/14-4744MR.1.
To prospectively assess the safety and efficacy of a novel absorbable vascular closure device (ExoSeal) in patients undergoing cardiac catheterization with femoral access compared to the established collagen-based (Angio-Seal) and suture-mediated (ProGlide) closure devices.
This prospective, observational, dual-center, non-randomized, non-blinded study enrolled 1013 patients (65.1 ± 11.8 years) undergoing cardiac catheterization via a common femoral artery access in which hemostasis was achieved using a vascular closure device (255 Angio-Seal, 258 ProGlide, and 500 ExoSeal). In hospital complications (bleeding, hematoma, pseudoaneurysm, vessel occlusion, dissection, and arteriovenous fistula) of the puncture site and device failures (persistent bleeding) were recorded and compared for ExoSeal vs. the established devices (Angio-Seal + ProGlide).
There were more complications after utilization of ExoSeal compared to established devices (3.6% vs. 1.2%, p=0.012). No significant difference was observed in the device success rate between the established vascular closure devices (96.3%) and the novel device (94.8%, p=0.28). Considering each closure system, Angio-Seal had the lowest complication rate (0.4%) and the highest efficacy (99.2%); the latter differed significantly from ExoSeal (94.8%, p=0.001). Logistic regression analysis revealed a >3-fold odds of complications when using ExoSeal, which remained unchanged in multivariate analysis.
Utilization of the novel vascular closure device is associated with a higher complication rate and a similar device failure rate compared to collagen-based and suture-mediated devices, with Angio-Seal having the lowest complication and device failure rates.
与已有的基于胶原蛋白的（Angio-Seal）和缝线介导的（ProGlide）血管闭合装置相比，前瞻性评估一种新型可吸收血管闭合装置（ExoSeal）在经股动脉途径进行心脏导管插入术患者中的安全性和有效性。
这项前瞻性、观察性、双中心、非随机、非盲研究纳入了1013例（65.1±11.8岁）经股总动脉途径进行心脏导管插入术的患者，其中使用血管闭合装置实现止血（255例使用Angio-Seal，258例使用ProGlide，500例使用ExoSeal）。记录穿刺部位的院内并发症（出血、血肿、假性动脉瘤、血管闭塞、夹层和动静脉瘘）以及装置故障（持续出血），并比较ExoSeal与已有的装置（Angio-Seal + ProGlide）。
与已有的装置相比，使用ExoSeal后出现的并发症更多（3.6%对1.2%，p = 0.012）。已有的血管闭合装置（96.3%）与新型装置（94.8%，p = 0.28）之间在装置成功率方面未观察到显著差异。考虑每种闭合系统，Angio-Seal的并发症发生率最低（0.4%），有效性最高（99.2%）；后者与ExoSeal（94.8%）有显著差异（p = 0.001）。逻辑回归分析显示使用ExoSeal时并发症的几率增加超过3倍，在多变量分析中这一情况保持不变。
与基于胶原蛋白的和缝线介导的装置相比，新型血管闭合装置的使用与更高的并发症发生率和相似的装置故障率相关，其中Angio-Seal的并发症和装置故障率最低。
