European Journal of Cardio-Thoracic Surgery, Vol 10, 727-733, Copyright © 1996 by European Association for Cardio-thoracic Surgery
Controlled clinical studies of fibrin sealant in cardiothoracic surgery- -a review
HK Kjaergard and JE Fairbrother
Department of Cardiothoracic Surgery, Gentofte University Hospital, Hellerup, Denmark.
OBJECTIVE: More than 2300 clinical papers have been published on the
surgical applications of fibrin sealant (FS), with the largest number in
the speciality of cardiothoracic surgery. The purpose of this review of the
literature was to find and evaluate controlled studies published in the
field of cardiothoracic surgery, to clarify the indications and emphasize
the benefits of FS available to the practising surgeon. METHODS: A database
of the surgical publications of FS was created. Up to the end of 1995, at
least 24 controlled clinical studies had been published; these may be
divided into 20 studies with a positive outcome and 4 studies where the
results were not different from the controls. In none of the studies was
the clinical result worse after the use of FS. RESULTS: In most of the
cardiac studies, FS was successfully used at bleeding sites in reoperations
and in congenital heart surgery. Postoperative bleeding may also be reduced
by the anterior mediastinal spray application of FS or by preparing woven
Dacron prostheses with the sealant. In addition, Fs has been found to
improve results after type A aortic disections and, by adding an antibiotic
to the sealant, the postoperative infection rate for active endocarditis of
the aortic root can be reduced. In pulmonary surgery FS can be used to
reduce pulmonary air leakage, however the results of some studies diverge
due to different clinical test conditions and the inclusion of only a small
number of patients in the "negative" studies. In none of the controlled
studies of esophageal surgery could FS prevent leakage from esophageal
anastomoses. CONCLUSIONS: Fibrin sealant is safe when it is applied
properly, but there is a learning curve for surgeons who start using it. An
autologous sealant or a sealant containing human instead of bovine thrombin
is preferred, since repeated use of bovine thrombin may induce
coagulopthies. The number of controlled clinical studies of FS is currently
increasing, with the majority of the papers revealing a beneficial effect
of FS when it is used as a hemostatic or sealing agent in cardiothoracic
surgery.
