Safety of the use of Tissucol Duo S in cardiovascular surgery: retrospective analysis of 2149 patients after coronary artery bypass grafting.

OBJECTIVE: Fibrin sealant is widely used in almost all fields of surgery and has proved to be an effective therapeutic tool in cardiothoracic surgery. Nevertheless, there have been concerns about early bypass graft occlusion associated with the use of fibrin glue. This analysis has been performed to assess the risks and benefits of Tissucol Duo S in coronary artery bypass grafting (CABG) surgery.
METHODS: Two thousand one hundred forty-nine patients were included in this retrospective study, 879 (40.9%) were intra-operatively treated with Tissucol Duo S fibrin glue, 1270 (59.1%) did not receive fibrin glue (control group). Patient characteristics were documented according to the EuroScore. Intra- and postoperative data were collected. Primary endpoint of this study was the 30-day all-cause mortality rate in the Tissucol Duo S treated group compared to the control group.
RESULTS: Mean age was 66.6+/-9.4 years, 76.3% of the patients were male. There was an increased 30-day-mortality rate in the Tissucol Duo S group compared to the control group (8.5 vs 3.5%, p<0.001). In order to determine if and to what extent the apparent fibrin effect might be due to confounding effects from covariates, an adjustment for potential confounding was done. However, multivariable adjustment did not reduce the risk of fibrin glue below an odds ratio of 2.2.
CONCLUSION: Although the apparent increase in mortality risk associated with the use of fibrin glue could not be eliminated statistically, we consider Tissucol Duo S fibrin glue a safe and effective therapeutic tool in CABG surgery when it is applied correctly. Due to the retrospective character of this study some detailed information about the indication for the use of fibrin glue and its application is missing which may be important cofactors for mortality. For further clarification a prospective randomized study may be useful.