CARDIOVASCULAR ENGINEERING

CARDIOVASCULAR
ENGINEERING

Journal for Extracorporeal Circulation, Assist Devices,Transplantation and Artificial Organs

Volume 2, 1997, No 3



The Vivostat System for the Automated Preparation of Autologous Fibrin Sealant

H. K. Kjaergard, J. E. Fairbrother, S. A. Cederholm-Williams, P. A. D. Edwardson, D. A. Hollingsbee, N.-E. Holm

Abstract:
Background: Fibrin sealant is used in cardiovascular and thoracic surgery as a hemostatic and adhesive agent and as a sealant of pulmonary air leak. Conventional fibrin sealants based on human fibrinogen prepared from pooled plasma donations and thrombin have not been licensed in several countries including the US because of concerns about infection. Methods: The Vivostat system is a new medical device for the preparation of an autologous fibrin sealant in the operating room. The system is fully automated and microprocessor controlled and incorporates three components: an automated processor unit, an automated applicator unit, and a disposable, single patient use unit which includes a prep set and a spraypen applicator. The biochemical process is initiated by batroxobin, which acts upon fibrinogen from the patient's plasma. The completion of the process depends entirely on endogenous thrombin in producing the sealant. No exogenous thrombin is added. Results: The preparation process was completed in 30 min. From 120 ml of the patient's blood the yield was 4.5 +/- 0.3 ml (mean +/- standard deviation) of fibrin sealant. Conclusion: It is possible to prepare autologous fibrin sealant with the Vivostat system in 30 minutes. No exogenous thrombin is added. The sealant can be used in cardiovascular surgery.

Keywords:
autologous fibrin sealant, batroxobin, cardiovascular surgery, hemostasis, fibrinogen, microprocessor, thrombin

Address for Correspondence:

Henrik K. Kjaergard
M.D.
Department of Cardiothoracic Surgery
Gentofte Hospital
Niels Andersens Vej 65
2900 Hellerup
Denmark

Reference:
(CVE. 1997; 2 (3): 204-206)


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