Fibrin glue in coronary artery bypass grafting operations: casting out the Devil with Beelzebub?

OBJECTIVE: Fibrin sealants are frequently used in aortocoronary bypass operations. Although they are considered to be clinically safe, we performed a retrospective analysis of our data to examine the possible side effects of Tissucol fibrin sealant, namely the acute thrombosis of grafts and native coronary arteries resulting in severe myocardial damage and patient deaths. METHODS: The data of 2716 patients (2001 male, 715 female) who received an aortocoronary bypass operation from November 1995 to December 1999 were studied retrospectively. Two groups (group 1: received Tissucol, group 2: no sealant used) were compared with respect to an a priori selected set of demographic and clinical variables and with respect to their effect on the outcome using bivariate tabulation. Multiple exploratory assessments of factors possibly related to fatal outcome were done by multiple logistic regression. RESULTS: Nine hundred ninety patients (group 1) received Tissucol, 1726 patients (group 2) did not receive it. Mean patient age was 64+/-9.1 years. Group 1 had a higher risk of death (7.8% vs 2.8%, p<0.001). The peak values of creatine kinase >500 and creatine kinase-myocardial band >50 were higher in group 1 than in group 2, p<0.001. Adjusted odds ratios for the risk of fatal outcome were: 2.01 for the use of Tissucol, 2.71 for patient age >70 years, 2.02 for aortic cross clamp time >90 min, 3.95 for postoperative ventricular fibrillation, 6.35 for postoperative cardiopulmonary resuscitation, 4.55 for postoperative aortocoronary reoperation. CONCLUSION: In our analysis an increased risk of myocardial injury or even death was found in coronary artery bypass grafting patients when Tissucol fibrin sealant was used intraoperatively.

A web-based central diagnostic data repository.

A central repository for diagnostic information about individual patients was created as a service to diagnostic laboratories participating in the Compentence Network for Acute and Chronic Leukemias in order to support health care delivery to patients suffering from leukemia. During the diagnostic phase several specialised laboratories perform different assays on samples from the same patient. The use of these assays in the diagnostic process and during the treatment phase may be improved in terms of both rapid delivery and cost if any one laboratory is aware of preliminary or final results from the assay carried out in other laboratories. In order to support a more efficient communication of these results, a central diagnostic data repository (CDDR) was created and web-based user interface was developed. Currently, the CDDR maintains documents in the form of portable document format (PDF) files. Several other formats are accepted and converted automatically upon entry. Patient identification is accomplished by pseudonym rather than proper name and the data is held on the CDDR for a limited time interval to accommodate the stringent privacy regulations in Germany. The principle operation of a CDDR may also be applied to the diagnostic or therapeutic process of other diseases.

A web-based randomisation service for clinical studies.

The Competence Network for Acute and Chronic Leukemias is one of several networks of competence, each directed at a specific disease. Within this context, a web-based randomisation service was designed and implemented as a service to participating study groups. It provides centralised randomisation for several study centres that is independent of each of the centres. In order to minimise difficulties in using this service arising from the fact that it is only needed fairly infrequently, the user interface was kept as simple as possible. The major advantages of a web-based service lie in its "unpredictability" and its continuous availability at all times without the need for around-the-clock personnel. The experience gained with this service in the context of the Competence Network with a relatively small number of actual users may provide the basis for a more widespread application.