VIVOSTAT SYSTEM AUTOLOGOUS FIBRIN SEALANT - PRELIMINARY-STUDY IN ELECTIVE CORONARY-BYPASS GRAFTING

Background. The Vivostat System is a medical device for the preparatio n of an autologous fibrin sealant from 120 mL of the patient's blood i n 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 th e fibrinogen in the patient's plasma. The completion of the process de pends entirely on endogenous thrombin in producing the sealant. Method s. Twenty-four volunteer patients undergoing elective primary coronary artery bypass grafting were randomized to either conventional hemosta sis (control group) or the use of Vivostat fibrin sealant as an adjunc t to conventional hemostasis. The patients were followed up at 1 month and 1 year. Results. The preparation process was completed in 30 minu tes. No safety issues associated with the use of the sealant were iden tified. 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 Vi vostat group, 1 of 11 patients (9%) required a perioperative transfusi on and in the control group 3 of 12 patients (25%) required a perioper ative transfusion. Conclusions. It is possible to prepare autologous f ibrin sealant with the Vivostat system in 30 minutes. No exogenous thr ombin is required. The sealant has no known adverse effects and may pr ove to be a useful adjunct to hemostasis in cardiothoracic surgery. (C ) 1998 by The Society of Thoracic Surgeons.