Guldner N W, Siemens H J, Schramm U, Kraatz E, Thuaudet S, Kuppe H, Sievers H H
Department of Cardiac Surgery, Medical University of Luebeck, Germany.
J Heart Lung Transplant. 1996 Mar;15(3):291-6.
The medos-HIA ventricular support system was designed as an artificial heart assist device for intractable heart failure to act as a bridge for transplantation or recovery. The aim of this study is to report on the first clinical application of the system and to evaluate the thrombotic risk with the use of the biomarker prothrombin fragment F1 + 2 and scanning electron microscopy of the blood contacting surface.
This device worked without any failure for 462 hours, and a sufficient output of 5.2 to 6 L was observed. No activation of the procoagulatory system occurred during pumping until the occurrence of the septicemia. Preseptic F1 + 2 levels were normal, at about 1 nmol/L. The blood contacting surfaces of the pump and the polyurethane valves were examined by means of scanning electron microscopy, and the surfaces were found to have smooth fibrin layers with no thrombogenic deposits. This fibrin layer is considered to prevent thrombotic adhesions, thereby minimizing the risk of thromboembolic complications. Post mortem examinations after pneumonia with septic shock showed no thrombus formation in this support system and around the inserted cannulas.
The low risk for thromboembolic complications, no measurable activation of the coagulation system, and the excellent surface characteristics encourage further use of this inexpensive working device.
美多斯-HIA心室支持系统被设计为用于治疗顽固性心力衰竭的人工心脏辅助装置，作为移植或康复的桥梁。本研究的目的是报告该系统的首次临床应用，并通过使用生物标志物凝血酶原片段F1 + 2以及对血液接触表面进行扫描电子显微镜检查来评估血栓形成风险。
该装置无故障运行462小时，观察到有5.2至6升的充足输出量。在发生败血症之前，泵血过程中未发生凝血系统激活。败血症前F1 + 2水平正常，约为1纳摩尔/升。通过扫描电子显微镜检查泵和聚氨酯瓣膜的血液接触表面，发现表面有光滑的纤维蛋白层，无血栓形成沉积物。该纤维蛋白层被认为可防止血栓粘连，从而将血栓栓塞并发症的风险降至最低。肺炎合并感染性休克后的尸检显示，该支持系统及插入插管周围未形成血栓。
血栓栓塞并发症风险低、凝血系统无明显激活以及良好的表面特性促使人们进一步使用这种价格低廉且运行良好的装置。
