Kjaergard H K, Trumbull H R
Department of Cardiothoracic Surgery, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.
Ann Thorac Surg. 1998 Aug;66(2):482-6. doi: 10.1016/s0003-4975(98)00470-6.
The Vivostat System is a medical device for the preparation of an autologous fibrin sealant from 120 mL of the patient's blood in the operating room. The system is fully automated and microprocessor controlled and is made up of three components: an automated processor unit, an automated applicator unit, and a disposable, single-patient-use unit, which includes a preparation set and a Spraypen applicator. The biochemical process is initiated by batroxobin, which acts upon the fibrinogen in the patient's plasma. The completion of the process depends entirely on endogenous thrombin in producing the sealant.
Twenty-four volunteer patients undergoing elective primary coronary artery bypass grafting were randomized to either conventional hemostasis (control group) or the use of Vivostat fibrin sealant as an adjunct to conventional hemostasis. The patients were followed up at 1 month and 1 year.
The preparation process was completed in 30 minutes. No safety issues associated with the use of the sealant were identified. From 120 mL of the patient's blood the yield of fibrin sealant was 4.5 mL (range, 3.9 to 4.8 mL). There was a favorable trend toward lower amounts of chest tube drainage in the Vivostat group. In the Vivostat group, 1 of 11 patients (9%) required a perioperative transfusion and in the control group 3 of 12 patients (25%) required a perioperative transfusion.
It is possible to prepare autologous fibrin sealant with the Vivostat system in 30 minutes. No exogenous thrombin is required. The sealant has no known adverse effects and may prove to be a useful adjunct to hemostasis in cardiothoracic surgery.
Vivostat系统是一种用于在手术室从120毫升患者血液中制备自体纤维蛋白密封剂的医疗设备。该系统完全自动化且由微处理器控制，由三个组件组成：一个自动处理器单元、一个自动涂抹器单元以及一个一次性、仅供单患者使用的单元，后者包括一个制备套件和一个喷雾笔涂抹器。生化过程由巴曲酶启动，其作用于患者血浆中的纤维蛋白原。该过程的完成完全依赖内源性凝血酶来生成密封剂。
24例接受择期初次冠状动脉搭桥术的志愿者患者被随机分为常规止血组（对照组）或使用Vivostat纤维蛋白密封剂作为常规止血辅助手段的组。对患者进行1个月和1年的随访。
制备过程在30分钟内完成。未发现与使用密封剂相关的安全问题。从120毫升患者血液中获得的纤维蛋白密封剂产量为4.5毫升（范围为3.9至4.8毫升）。Vivostat组的胸管引流量有减少的良好趋势。在Vivostat组中，11例患者中有1例（9%）需要围手术期输血，而在对照组中，12例患者中有3例（25%）需要围手术期输血。
使用Vivostat系统可在30分钟内制备出自体纤维蛋白密封剂。无需外源性凝血酶。该密封剂无已知不良反应，可能被证明是心胸外科手术中止血的有用辅助手段。
