Thromboembolic and bleeding complications in patients with mechanical heart valve prostheses. 1994

S C Cannegieter, and F R Rosendaal, and E Briët
Department of Hematology, University Hospital Leiden, The Netherlands.

BACKGROUND Patients with mechanical heart valve prostheses may experience valve thrombosis and subsequent systemic embolism for which they are treated with oral anticoagulant therapy. It is essential to know reliable estimates of the risks and benefits of this therapy in order to answer a number of clinical questions rationally. We sought to obtain more precise estimates of the risks and benefits by combining the data from individual studies by using meta-analysis. RESULTS We searched for studies in which the incidences were reported of embolic or bleeding complications in patients with mechanical heart valve prostheses. They were collected from the Medline and Current Contents database and by cross-references between 1970 and 1992. Since most studies vary greatly in many respects, we used a number of inclusion criteria, thus selecting comparable studies of acceptable quality only. The influence of antithrombotic therapy, valve position, and valve type was analyzed by univariate and by multivariate analysis with Poisson regression techniques. Forty-six studies were found, including 13,088 patients studied for 53,647 patient-years. We found an incidence of major embolism in the absence of antithrombotic therapy of 4 per 100 patient-years. With antiplatelet therapy this risk was 2.2 per 100 patient-years, and with coumarin therapy it was reduced to 1 per 100 patient-years. This risk varied with the type and the site of the prosthesis. A prosthesis in mitral position increased the risk almost twice as compared with the aortic position. Tilting disc valves and bileaflet valves showed a lower incidence of major embolism than caged ball valves. An incidence of major bleeding was found in patients treated with coumarin derivatives of 1.4 per 100 patient-years. The incidence of bleeding became significantly higher with the addition of antiplatelet therapy, although this did not decrease the risk of thromboembolism any further. CONCLUSIONS These data provide a reference for future studies and give adequate risk estimates for clinical decision making.

UI MeSH Term Description Entries
D004867 Equipment Design Methods and patterns of fabricating machines and related hardware. Design, Equipment,Device Design,Medical Device Design,Design, Medical Device,Designs, Medical Device,Device Design, Medical,Device Designs, Medical,Medical Device Designs,Design, Device,Designs, Device,Designs, Equipment,Device Designs,Equipment Designs
D006349 Heart Valve Diseases Pathological conditions involving any of the various HEART VALVES and the associated structures (PAPILLARY MUSCLES and CHORDAE TENDINEAE). Heart Valvular Disease,Valvular Heart Diseases,Disease, Heart Valvular,Heart Disease, Valvular,Heart Valve Disease,Heart Valvular Diseases,Valve Disease, Heart,Valvular Disease, Heart,Valvular Heart Disease
D006350 Heart Valve Prosthesis A device that substitutes for a heart valve. It may be composed of biological material (BIOPROSTHESIS) and/or synthetic material. Prosthesis, Heart Valve,Cardiac Valve Prosthesis,Cardiac Valve Prostheses,Heart Valve Prostheses,Prostheses, Cardiac Valve,Prostheses, Heart Valve,Prosthesis, Cardiac Valve,Valve Prostheses, Cardiac,Valve Prostheses, Heart,Valve Prosthesis, Cardiac,Valve Prosthesis, Heart
D006470 Hemorrhage Bleeding or escape of blood from a vessel. Bleeding,Hemorrhages
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000925 Anticoagulants Agents that prevent BLOOD CLOTTING. Anticoagulant Agent,Anticoagulant Drug,Anticoagulant,Anticoagulant Agents,Anticoagulant Drugs,Anticoagulation Agents,Indirect Thrombin Inhibitors,Agent, Anticoagulant,Agents, Anticoagulant,Agents, Anticoagulation,Drug, Anticoagulant,Drugs, Anticoagulant,Inhibitors, Indirect Thrombin,Thrombin Inhibitors, Indirect
D013923 Thromboembolism Obstruction of a blood vessel (embolism) by a blood clot (THROMBUS) in the blood stream. Thromboembolisms
D015999 Multivariate Analysis A set of techniques used when variation in several variables are studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables. Analysis, Multivariate,Multivariate Analyses
D016019 Survival Analysis A class of statistical procedures for estimating the survival function (function of time, starting with a population 100% well at a given time and providing the percentage of the population still well at later times). The survival analysis is then used for making inferences about the effects of treatments, prognostic factors, exposures, and other covariates on the function. Analysis, Survival,Analyses, Survival,Survival Analyses

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