Early clinical evaluation of a new Björk-Shiley valve prosthesis with integral monostrut

We evaluated preliminary results of valve replacement with a new Björk-Shiley valve prosthesis with integral monostrut. Sixty-five valves were implanted in 56 patients (18 aortic, 30 mitral, 7 double, 1 triple). The age of the patients ranged from 30 to 62 years, and they were followed up for 7-17 months (mean, 12.5 months). There were three operative deaths (5.3%) not related to the prosthesis and no late deaths. Minor cerebral thromboembolism occurred in one patient 2 weeks after surgery despite anticoagulant therapy. Intraoperative transvalvular pressure gradients across the 23-mm aortic and 27-mm mitral valve prostheses were insignificant. Real-time two-dimensional echocardiography revealed no regurgitation at the moment of valve closure in 20 randomly selected patients. Though the data accumulated so far are still relatively incomplete and the follow-up periods short, the clinical results obtained here were satisfactory, warranting further use of this new Björk-Shiley valve prosthesis with integral monostrut for longer follow-up studies.