Silber S, Gershony G, Schön B, Schön N, Jensen T, Schramm W
Department of Cardiology, Dr. Müller Hospital, Munich, Germany.
Am J Cardiol. 1999 Apr 15;83(8):1248-52. doi: 10.1016/s0002-9149(99)00067-3.
The purpose of this study was to investigate the safety and efficacy of a novel vascular sealing device that incorporates a unique low-profile balloon-positioning catheter and a procoagulant delivered after diagnostic cardiac catheterization and percutaneous transluminal coronary angioplasty (PTCA) procedures. Current management of the vascular access site after percutaneous interventions is associated with patient discomfort and complications. Based on previously reported successful results in canine models, we proceeded with this first human feasibility and safety study. Immediately after an invasive procedure, the sealing device was successfully deployed at the femoral arterial access site in 24 of 24 procedures (diagnostic 19, PTCA 5). All patients were followed up at 1 month with clinical assessment, ankle-brachial index measurement, and Doppler ultrasound. Successful hemostasis was achieved in all patients. The activated clotting time before sealing device deployment was 125.5 +/- 22.2 and 267.8 +/- 60.0 seconds for diagnostic and PTCA patients, respectively. The time to hemostasis was 2.5 +/- 0.9 minutes for diagnostic and 6.0 +/- 2.2 minutes for PTCA patients. No major complications were observed. Coagulation markers (fibrinogen, D-dimer, thrombin-antithrombin-3 complex, and prothrombin fragment 1 and 2) measured before and after sealing device deployment did not reveal excessive intravascular thrombin generation or other coagulopathy. This novel vascular sealing device successfully achieves safe and effective vascular access site hemostasis immediately after cardiac catheterization and PTCA. These promising first human results will need to be confirmed by a multicenter randomized trial.
本研究的目的是调查一种新型血管封闭装置的安全性和有效性，该装置包含独特的低轮廓球囊定位导管以及在诊断性心导管插入术和经皮腔内冠状动脉成形术（PTCA）后输送的促凝剂。经皮介入术后血管穿刺部位的当前管理与患者不适和并发症相关。基于先前在犬类模型中报道的成功结果，我们开展了这项首次人体可行性和安全性研究。侵入性手术后，该封闭装置在24例手术中的24个股动脉穿刺部位成功部署（诊断性手术19例，PTCA手术5例）。所有患者在1个月时接受临床评估、踝臂指数测量和多普勒超声检查。所有患者均实现了成功止血。对于诊断性手术和PTCA手术患者，在部署封闭装置前的活化凝血时间分别为125.5±22.2秒和267.8±60.0秒。诊断性手术患者的止血时间为2.5±0.9分钟，PTCA手术患者为6.0±2.2分钟。未观察到重大并发症。在部署封闭装置前后测量的凝血标志物（纤维蛋白原、D - 二聚体、凝血酶 - 抗凝血酶 - 3复合物以及凝血酶原片段1和2）未显示血管内凝血酶生成过多或其他凝血病。这种新型血管封闭装置在心脏导管插入术和PTCA术后可立即成功实现安全有效的血管穿刺部位止血。这些有前景的首次人体研究结果需要通过多中心随机试验来证实。
