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Ann Thorac Surg 1998;66:101-107
© 1998 The Society of Thoracic Surgeons

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Original articles: cardiovascular

Thromboembolism and mechanical heart valves: a randomized study revisited

^a Department of Cardiothoracic Surgery, University Hospital Groningen, Groningen, the Netherlands

Accepted for publication February 18, 1998.

Address reprint requests to Dr Kuntze, Thorax Centre, University Hospital Groningen, Achterberghof 18, 9752 HE Haren, the Netherlands

Background. This study was designed to revise and substantiate previous inferences, based on short-term follow-up, about differences in the incidence of anticoagulant-related events after heart valve replacement among patients who had been randomly assigned to receive either a Björk-Shiley, Edwards-Duromedics, or Medtronic-Hall mechanical heart valve prosthesis.

Methods. Intermediate-term follow-up to January 1995 was completed in 418 of 419 patients randomized to receive one of three types of heart valve prostheses between January 1982 and January 1987. Median follow-up was 98.5 months. Multivariable analysis in the hazard function domain was performed to identify factors that influenced the incidence of time-related thromboembolism and bleeding. These findings were compared with those made previously after a median follow-up of 37.5 months.

Results. No differences were found among the three prostheses in rates of anticoagulant-related hemorrhage. However, the incidence of thromboembolism was higher after mitral valve replacement among patients who had received the Medtronic-Hall prosthesis (linearized rate, 5.4% per patient year; 70% confidence interval, 4.0% to 7.1%), compared with Edwards-Duromedics (1.3%; 70% confidence interval, 0.4% to 3.0%) and Björk-Shiley prostheses (1.2%; 70% confidence interval, 0.6% to 2.2%).

Conclusions. At long-term follow-up, in contrast to the findings at short-term follow-up, patients with either Björk-Shiley or Edwards-Duromedics prostheses had low rates of thromboembolism, whereas higher rates occurred in patients with a Medtronic-Hall prosthesis in the mitral position.

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